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

Model Number	6481-1-101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2023
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
Patient reported for revision surgery due to query of failed mrh component.Confirmed during surgery that mrh distal femur and stem extender had broken and detached.Impact: revision surgery convert mrh to distal femur gmrs.Procedure: mrh to proximal femur gmrs reconstruction revision.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via visual inspection of the provided photographs of the device.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the devices indicate that the devices have been recently explanted and are covered in blood/tissue and bone cement.A portion of the threaded junction of the femoral component appears to have fractured off.It also appears that a fractured portion of the stem extender remains threaded into the femoral component.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: it was reported that the patient was revised due to fracture at the stem/femoral component interface.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the devices indicate that the devices have been recently explanted and are covered in blood/tissue and bone cement.A portion of the threaded junction of the femoral component appears to have fractured off.It also appears that a fractured portion of the stem extender remains threaded into the femoral component.Further information such as return of the devices, 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient reported for revision surgery due to query of failed mrh component.Confirmed during surgery that mrh distal femur and stem extender had broken and detached.Impact: revision surgery convert mrh to distal femur gmrs procedure: mrh to proximal femur gmrs reconstruction revision.

• Brand Name: MRH KNEE FEM XS RHT
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16973536
• Report Number: 0002249697-2023-00568
• Device Sequence Number: 20495356
• Product Code: KRO
• UDI-Device Identifier: 07613327045123
• UDI-Public: 07613327045123
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 10/31/2022
• Device Model Number: 6481-1-101
• Device Catalogue Number: 64811101
• Device Lot Number: CY94L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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: 19 YR
• Patient Sex: Male