MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 23X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6478-6-665
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
Its reported by the attorney, through the filing of a legal claim, that the patient underwent knee surgery on (b)(6) 2016 due to a fractured left proximal tibial allograft, catastrophic failure, left alloprosthetic arthroplasty.It's further alleged that the patient underwent one stage left knee endoprosthetic revision, radical synovectomy on (b)(6) 2019 due to infection.
Event or Problem Description
Its reported by the attorney, through the filing of a legal claim, that the patient underwent knee surgery on (b)(6) 2016 due to a fractured left proximal tibial allograft, catastrophic failure, left alloprosthetic arthroplasty.It's further alleged that the patient underwent one stage left knee endoprosthetic revision, radical synovectomy on (b)(6) 2019 due to infection.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving ti dur reg fluted stem 23x80mm was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays were rejected by a clinical consultant stated the following comment: cannot confirm event, need additional information; revision operative reports, clinical and past medical history, additional serial dated x-rays, unlabeled photo showing dark material needs surgical pathology to confirm metallosis and pathology and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.No other similar events for the sterile lot referenced.Conclusion: it was reported that the patient was revised due to infection and metallosis caused by defective stryker product.The reported event cannot be confirmed or the exact cause of the event cannot be determined as insufficient information was provided.Additional information including operative reports, progress notes, x-rays, pathology reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: TI DUR REG FLUTED STEM 23X80MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9696420
• Report Number: 0002249697-2020-00269
• Device Sequence Number: 16613578
• Product Code: JWH
• UDI-Device Identifier: 07613327044973
• UDI-Public: 07613327044973
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 11/30/2020
• Device Model Number: 6478-6-665
• Device Catalogue Number: 64786665
• Device Lot Number: 0040531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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: 54 YR