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

Catalog Number	64811121
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/29/2024
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Revision of mrh knee to distal femur gmrs.Cause of revision fractured femoral component.
Event or Problem Description
Revision of mrh knee to distal femur gmrs.Cause of revision fractured femoral component.
Additional Manufacturer Narrative
An event regarding crack/fracture and loosening involving a mrh femoral component was reported.The event was confirmed evaluation of the returned device.Method & results: device evaluation and results: visual inspection: visual inspection of the returned devices was performed as part of the material analysis: "images show the mrhk femoral component, with fracture.On visual examination, fracture of the stem within the femoral post of the femoral component was observed.Also visible in images are the tibial rotating component and bumper insert.Bone cement was observed on the proximal surface of the femoral component." functional, and dimensional inspections were not performed as the device was returned damaged.Material analysis: a material analysis was performed on the returned device which concluded the following: "characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the stem due to fatigue, with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined." clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient was revised due to fracture.A material analysis was performed on the returned device which concluded the following: characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the stem due to fatigue, with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined.On visual examination, fracture of the stem within the femoral post of the femoral component was observed.Also visible in images are the tibial rotating component and bumper insert.Bone cement was observed.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRH KNEE FEM M RGT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18987932
• Report Number: 0002249697-2024-00507
• Device Sequence Number: 11492764
• Product Code: KRO
• UDI-Device Identifier: 07613327045161
• UDI-Public: 07613327045161
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 08/31/2025
• Device Catalogue Number: 64811121
• Device Lot Number: JSL4E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male