MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 13X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6485-3-113

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 09/09/2019

Event Type  Injury  

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 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.

Manufacturer Narrative

Reported event: an event regarding infection involving mrs fem stem w/o body 13x127mm 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 also 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.

Event 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.

• Brand Name: MRS FEM STEM W/O BODY 13X127MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9696417
• MDR Text Key: 188708697
• Report Number: 0002249697-2020-00268
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327048377
• UDI-Public: 07613327048377
• Combination Product (y/n): N
• PMA/PMN Number: K040749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 6485-3-113
• Device Catalogue Number: 64853113
• Device Lot Number: 167169B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR