MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S RGT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64811111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding crack/fracture involving an mrh femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device lot id, operative reports, progress notes, x-rays 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.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.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient experienced problems with this device in (b)(6) 2018.It is further alleged that due to pain with weight bearing a work up was done and the prosthetic cracked and fractured along the femoral component neat or at the location of the hinge.The patient was revised on (b)(6) 2018.

• Brand Name: MRH KNEE FEM S RGT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9305290
• Report Number: 0002249697-2019-03721
• Device Sequence Number: 2310956
• Product Code: KRO
• UDI-Device Identifier: 07613327045147
• UDI-Public: 07613327045147
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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 Catalogue Number: 64811111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/11/2019
• 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