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

Catalog Number	64811111
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/31/2023
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.
Event or Problem Description
It was reported that the patient's right hinged knee was revised after patient complaint of thigh pain.Surgeon originally suspected femoral loosening.However, intra-op it was observed that the lateral condyle of the femoral component broke off of the implant and was loose in the joint.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and loosening involving a mrh femoral component was reported.The event was confirmed for crack/fracture.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component with fractured condyle.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 had pain; intraop it was observed that the implant was fractured and loose.The reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component with fractured condyle.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
It was reported that the patient's right hinged knee was revised after patient complaint of thigh pain.Surgeon originally suspected femoral loosening.However, intra-op it was observed that the lateral condyle of the femoral component broke off of the implant and was loose in the joint.

• Brand Name: MRH KNEE FEM S 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17805312
• Report Number: 0002249697-2023-01071
• Device Sequence Number: 20219037
• Product Code: KRO
• UDI-Device Identifier: 07613327045147
• UDI-Public: 07613327045147
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023
• 2 Devices were Involved in the Event: 1 2

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: 05/18/2023
• Device Catalogue Number: 64811111
• Device Lot Number: DP63C
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 09/24/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female