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Recall Observatory FDA recall evidence

Device product

Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head

Z-0683-2017

June 21, 2016

Class III

Product summary

Firm
MicroPort Orthopedics Inc.
Event
Event 75063
Status
Terminated
Classification
Class III
Quantity
5,009 units
Official record key
device-enforcement:Z-0683-2017

Official wording

Reason: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Code information: REF 70102846 Serial numbers: 06217334, 06217335, 06217336, 07218879, 10229555, 12339970, 12342378, 09345262, 11356669, 03459689, 03460757, 05478476, 06487845, 09491060, 11497839, 114131987, 025179937, 035198678, 035199154, 075211008, 085258159, 095267627, 085267672, 125294335, 016302354, 026317823, 026322014, 056332874, 056340972, 066346343, 066347890, 066349011, 076361472, 086364785, 086365941, 086365942, 086366614, 027403696, 027405367, 037417244, 037417245, 037423200, 047423201, 057426382, 057436510, 067442040, 067445874, 067447459, 077449134, 077456252, 077456253, 077458343, 087458991, 097465277, 097465278, 107473197, 097476410, 107481165, 107485823, 107486701, 117486702, 117495033, 127500338, 127500339, 038523902, 028523903, 028533974, 028533976, 038533977, 048571510, 048571511, 078595472, 078595473, 108669048, 108694963, 108694964, 118706230, 029763680, 029780243, 069816370, 069829627, 069835276, 069840533, 069841537, 069842578, 069871618, 099893231, 0301059446, 0301059448, 0301059449, 0301076824, 0301080515, 0301084486, 0301084488, 0301085776, 0301089607, 0301089608, 0401112808, 0601145034, 0601146232, 0801172562, 0801172985, 1101217377, 1381687, 1382260 REF 70202852 Serial Numbers: 06217338, 03442273, 03457113, 094103603, 114115155, 114131988, 067444763, 097458085, 117501995, 018507062, 078595474, 022A147720 REF 70202852 Serial Numbers: 022A147721, 022A147722, 022A147723, 022A147723, 022A147724, 06217340, 04217341, 04217342, 04217343, 04218880, 05218881, 04218882, 08225650, 08227481, 08227482, 10228744, 11228846, 03334611, 05335140, 03339967, 03339968, 08342274, 09345234, 08345235, 10349867, 10349868, 10349869, 03455651, 03457114, 03460758, 05478475, 06487846, 08491061, 08497840, 08499658, 094103604, 114115156, 114131989, 015140898, 015145854, 015167730, 025182498, 025182499, 025185569, 035198684, 055208762, 055228595, 055229916, 065242431, 075242432, 065245652, 085258160, 095267361, 095267673, 085267674, 105281165, 115291529, 125292876, 115292878, 016311871, 016311871, 016311872, 026316752, 026317146, 026317824, 026319568, 046326036, 046329102, 056331319, 056342436, 056344951, 066346344, 066349010, 076361473, 086364783, 086365943, 106369766, 116371021, 116373886, 116382786, 037399873, 027403168, 027403697, 027405368, 027408532, 027408593, 027408594, 027409933, 037417800, 037420888, 047423580, 057431859, 057436511, 067444764, 067445875, 067447445, 067447455, 077449135, 077452390, 077453351, 077457329, 097458992, 087459274, 087464167, 087464168, 097464169, 087466761, 087466762, 087466763, 097471664, 107476411, 107481166, 107481167, 107481168, 107488772, 107488773, 117488774, 117500335, 117500336, 127500337, 018507065, 028507066, 028533978, 028533979, 038533980, 038533981, 068571512, 068571513, 068595475, 068595477, 068628972, 078657275, 078657276, 088657277, 088657277, 088666909, 088668637, 088681722, 098688681, 098688682, 108694972, 108694973, 108694974, 108706231, 019744517, 029744518, 029752395, 029752396, 019780244, 069805762, 059805763, 049826202, 039826203, 059832457, 069837384, 059840534, 069841535, 069841536, 069843282, 079843284, 079871619, 099893232, 099894028, 109943611, 109949751, 119976454, 129984899, 0101009599, 0101019757, 0101048257, 0201049093, 0301049096, 0301064289, 0301064290, 0301076825, 0401079670, 0401079671, 0401089609, 0401089610, 0401108733, 0401109165, 0501137724, 0601138315, 0601138736, 0601142035, 0801177943, 0801178058, 0701179671, 0801189482, 0801189732, 1101214882, 1001214883, 1101215441, 0511308183, 0511308908, 0511311535, 1379458, 1379459, 1379605, 1381323, 1384695 REF 70302858 Serial Numbers: 04217339, 10228742, 09491063, 056340187, 106369767, 106373887 REF 70303258 Serial Numbers: 022A147725, 022A147726, 022A147727, 022A147739, 04217344, 04217345, 04217346, 08225648, 08225648, 08227483, 10228741, 10230588, 05335139, 11339972, 03449870, 03460759, 05478477, 06487847, 08491062, 08497841, 114131990, 114131991, 015155783, LLALMD033E, 075208766, 085258161, 125294334, 016308023, 056333740, 066347206, 086364784, 116366898, 116382787, 037417544, 047420889, 057431860, 057436512, 067445876, 067447458, 077451556, 097458361, 097475906, 107481169, 117481170, 107489026, 127500332, 117500333, 127500334, 018507067, 028533983, 098625460, 108716003, 029753067, 079828958, 069843288, 0201044697, 0401085943, 0401092474, 0401092475, 0401106375, 0401107035, 0501132274, 0601143641, 0601151739, 0701165736, 0901197191, 1388534 REF 70402864 Serial numbers: 11228743, 056339647, 066347891 REF 70403264 Serial numbers: 08228131, 056330591 REF 70403664 Serial Numbers: 062A147184, 062A147738, 06217348, 09339971, 11355652, 03457115, 03460761, 05478478, 015140899, 055199111, 075241210, 016303424

Distribution pattern: Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.