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

Catalog Number	64811110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/21/2025
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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The following was reported: "it broke while implanted in the patient.The surgery took place in (b)(6) 2019.It has been removed and replaced.During a revision it was patient reported pain.".
Additional Manufacturer Narrative
Corrected data: date of implant.An event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices was performed as part of the material analysis: "the images depicted show the mrh knee femoral component, fluted stem, and femoral bushings with fracture of the femoral component highlighted with arrows.On visual examination, fracture of the lateral condyle of the femoral component was observed.Images of the fracture surface associated with the (a) mrh knee femoral component and (b) detached piece of the mrh knee femoral component, respectively.Explantation damage was observed on the mrh knee femoral component, adjacent to the fracture surface." material analysis: a material analysis was performed on the returned device which concluded the following: "review of the mrh knee femoral component, catalogue # 6481-1-110, lot code ee62h, fluted stem, catalogue # 6478-6-635, lot code 0066264, and mrhk femoral bushings, catalogue # 6481-2-110, lot code lhr619 confirmed fracture of the lateral condyle of the femoral component.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the femoral component in fatigue.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.Product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the femoral component.A material analysis was performed on the returned device which concluded the following: "review of the mrh knee femoral component, catalogue # 6481-1-110, lot code ee62h, fluted stem, catalogue # 6478-6-635, lot code 0066264, and mrhk femoral bushings, catalogue # 6481-2-110, lot code lhr619 confirmed fracture of the lateral condyle of the femoral component.Characterisation using visual, stereo microscope, and secondary electron imaging confirmed fracture of the femoral component in fatigue.No manufacturing or material related defects were observed on the device surfaces examined." further information such as pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.
Event or Problem Description
No new information.

• Brand Name: MRH KNEE FEM S LFT
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23543622
• Report Number: 0002249697-2025-01334
• Device Sequence Number: 9719350
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: 07613327045130
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 11/30/2023
• Device Catalogue Number: 64811110
• Device Lot Number: EE62H
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown