MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN POLY LINER; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.Not returned to the manufacturer.

Event Description

Rep reported a hip revision.Accompanying explant pictures reveal a stem with a sheared-off trunnion, a femoral head, and a poly liner with very evident wear at one point of its rim.Patient was revised to a restoration modular stem.

Manufacturer Narrative

An event regarding damage of an unknown liner due to impingement was reported.The event was confirmed based on the photographs of the explants provided and the clinician review.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted liner.There is damage on the rim of the liner visible from the photographs provided.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: cup malposition in absent anteversion and far medialization has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing corrosion between femoral head and stem taper leading to progressive metal substance loss with ultimately a fatigue fracture of the trunnion with catastrophic failure and metallosis requiring revision.-device history review: not performed as the lot id was not provided.-complaint history review:not performed as the lot id was not provided.Conclusion: the event was confirmed based on the photographs of the explant provided and the clinician review.Clinician review of the provided medical records and x-rays by a clinical consultant indicated: cup malposition in absent anteversion and far medialization has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing corrosion between femoral head and stem taper leading to progressive metal substance loss with ultimately a fatigue fracture of the trunnion with catastrophic failure and metallosis requiring revision.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Rep reported a hip revision.Accompanying explant pictures reveal a stem with a sheared-off trunnion, a femoral head, and a poly liner with very evident wear at one point of its rim.Patient was revised to a restoration modular stem.

• Brand Name: UNKNOWN POLY LINER
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7620085
• MDR Text Key: 111702608
• Report Number: 0002249697-2018-01895
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR