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 Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2024
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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Revision of proximal tibia gmrs, with mrh femur as patient was symptomatic.Found on investigation that mrh femur had broken at condyle.
Additional Manufacturer Narrative
An event regarding crack/fracture and loosening involving a mrh femoral component was reported.The event was confirmed via provided photographs of the device as well as clinician review of the provided medical records.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 biological material.One condyle of the femoral component has fracture off.-clinician review: a review of the provided medical records by a clinical consultant indicated: "assessment/conclusion: very little medical data was presented.No preoperative or postoperative medical information or patient history were presented.X-rays show a long stem hinge style implant with a proximal tibial replacement.There appears to be loosening of the femoral component.But again, sequential radiographs were not available.A photograph of what is presumed to be the same prosthesis shows fracture of what appears to be the medial femoral condyle at the junction into the box.Event confirmation: a fractured femoral implant can be confirmed.Patient's symptoms cannot be confirmed.Root cause: a root cause of the implant fracture cannot be determined with the information provided." -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 biological material.One condyle of the femoral component has fracture off.A review of the provided medical records by a clinical consultant indicated: "assessment/conclusion: very little medical data was presented.No preoperative or postoperative medical information or patient history were presented.X-rays show a long stem hinge style implant with a proximal tibial replacement.There appears to be loosening of the femoral component.But again, sequential radiographs were not available.A photograph of what is presumed to be the same prosthesis shows fracture of what appears to be the medial femoral condyle at the junction into the box.Event confirmation: a fractured femoral implant can be confirmed.Patient's symptoms cannot be confirmed.Root cause: a root cause of the implant fracture cannot be determined with the information provided." further information such as return of the device 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
Revision of proximal tibia gmrs, with mrh femur as patient was symptomatic.Found on investigation that mrh femur had broken at condyle.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18711128
• Report Number: 0002249697-2024-00235
• Device Sequence Number: 8192194
• 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: 2011
• 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): 06/06/2024

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: 10/31/2014
• Device Catalogue Number: 64811121
• Device Lot Number: SNX7N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2009
• 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: 28 YR
• Patient Sex: Male