Device product
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Z-0825-2015
Product summary
- Event
- Event 69984
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 units worldwide
- Official record key
device-enforcement:Z-0825-2015
Official wording
Reason: Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
Code information: Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
Distribution pattern: Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
Derived failure modes
-
Unknown
Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the