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

Model Number	6481-1-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At the outpatient check-up on (b)(6) 2022, the x-rays showed rupture of the femoral stem with a disconnection between the mrh component of the femoral prosthetic shield and the femoral stem.On (b)(6) 2022, the complete revision surgery of the mrh size small femoral component and new 15x155mm femoral stem were performed.
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.The following devices were also listed in this report: ti dur reg fluted stem 10x80mm; cat # 64786600; lot # m51s3.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "it is difficult to provide any real information regarding the case with the limited information.There is a hinge style implant in the knee.A single view unlabeled x-ray was provided (the second x-ray was obscured).On the x-ray the femoral stem appears angulated compared to the housing of the femoral implant.The event description indicated a revision was performed.Conclusion/assessment: apparent implant fracture or junctional fracture of the stem implant interface of a tumor style long stemmed hinged knee event confirmation: a fatigue failure of the stem at the housing interface of the femoral implant appears to have occurred.Root cause: a root cause for the implant failure cannot be determined from the materials 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.A review of the provided x-rays by a clinical consultant confirmed the event but was unable to identify root cause.It is unclear from the x-rays which component fractured, if not both.Further information such as return of the devices, additional 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
At the outpatient check-up on (b)(6) 2022, the x-rays showed rupture of the femoral stem with a disconnection between the mrh component of the femoral prosthetic shield and the femoral stem.On (b)(6) 2022, the complete revision surgery of the mrh size small femoral component and new 15x155mm femoral stem were performed.

• Brand Name: MRH KNEE FEM XS 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15964906
• Report Number: 0002249697-2022-01806
• Device Sequence Number: 12150121
• Product Code: KRO
• UDI-Device Identifier: 07613327045109
• UDI-Public: 07613327045109
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: 06/30/2015
• Device Model Number: 6481-1-100
• Device Catalogue Number: 64811100
• Device Lot Number: STM3L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 01/28/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2010
• 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: 35 YR
• Patient Sex: Unknown