Device product
Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
Z-1043-2015
Product summary
- Event
- Event 70100
- Status
- Terminated
- Classification
- Class II
- Quantity
- seven units
- Official record key
device-enforcement:Z-1043-2015
Official wording
Reason: Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
Code information: 510K 983382 Lot code 49073501
Distribution pattern: Nationwide Distribution including NY, OH, PA, and TX.
Derived failure modes
-
Unknown
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.