MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° CROSSFIRE INSERT 28 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-00-28G
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Discomfort (2330); Injury (2348)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding wear involving a trident liner was reported.The event was confirmed.Method & results: -product evaluation and results: a visual inspection of the returned device by a material analysis engineer noted; the proximal and distal surfaces of the insert.Damage consistent with the explantation process and contact against the stem were observed on the insert.Scratches were observed on the insert (figure 13).This is a common damage mode of uhmwpe.A material analysis concluded; damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the head taper and the stem trunnion losing their taper lock.Scratches were observed on the insert, which is a common damage mode of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records by a clinical consultant noted; the mar confirms there were no device-related matters present although otherwise the cause of the problem remains obscure due to lack of information although i am not sure whether additional clinical information would solve the problem.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including office/clinical notes, histopathology and serial x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The patient had increasing discomfort in this right hip in fall and since (b)(6).The x-ray image of (b)(6) 2017 (lumbar spine ap with hip cut) shows a concentric situation and a correctly placed head on the cone of the right hip.On (b)(6) 2018, misalignment of the head on the cone and visible ossification, could be seen on x-ray image for the first time; abrasion.

• Brand Name: TRIDENT 0° CROSSFIRE INSERT 28 MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7942419
• Report Number: 0002249697-2018-03226
• Device Sequence Number: 16560244
• Product Code: LPH
• UDI-Device Identifier: 07613327037449
• UDI-Public: 07613327037449
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2008
• Device Catalogue Number: 621-00-28G
• Device Lot Number: 97226201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 76