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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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
Revision surgery mrh femur, gmrs proximal tibia.Condyle lateral of mrh femur discovered to be broken.Revision surgery to distal femur replacement.
Event or Problem Description
Revision surgery mrh femur, gmrs proximal tibia.Condyle lateral of mrh femur discovered to be broken.Revision surgery to distal femur replacement.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection of the returned device shows the mrh knee femoral component fractured.There is explanation damage on the lateral side of the mrh femoral component.The region near the fracture surface of the lateral condyle with evidence of explantation damage observed.Material analysis indicated characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the lateral condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the components -clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 lot referenced.Conclusions: crack/fracture was reported visual inspection of the returned device shows the mrh knee femoral component fractured.There is explanation damage on the lateral side of the mrh femoral component.The region near the fracture surface of the lateral condyle with evidence of explantation damage observed.Material analysis indicated characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the lateral condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the components.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 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: 19400270
• Report Number: 0002249697-2024-00787
• Device Sequence Number: 8456039
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: 07613327045130
• 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: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 07/31/2019
• Device Catalogue Number: 64811110
• Device Lot Number: EJ8SL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2014
• 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: 24 YR
• Patient Sex: Female