MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 11X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Perforation (2001); Injury (2348)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
As reported: "femoral components were revised due to perforation of the femoral cortex by the intramedullary stem.No other complaints reported".Spoke to rep.Possible cause or contributor for perforation not reported to rep.A revision usage sheet with gmrs/ mrs components (distal femur, axle, bumper insert, long curved cemented stem, bushing) was provided.Rep reported that no further information will be released by the hospital or surgeon.

• Brand Name: MRS FEM STEM W/O BODY 11X127MM
• 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: 8830762
• Report Number: 0002249697-2019-02686
• Device Sequence Number: 2537247
• Product Code: KRO
• UDI-Device Identifier: 07613327048360
• UDI-Public: 07613327048360
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 64853111
• Device Lot Number: 159554G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/26/2019
• 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
• Patient Age: 75 YR