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

Model Number	6481-2-120
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required a revision of the components.It was further reported that the patient suffered an acute fall with hyperextension in march 2022.An audible clicking was reported as a result.Patient experienced 'instability' in july 2022.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient required a revision of the components.It was further reported that the patient suffered an acute fall with hyperextension in (b)(6) 2022.An audible clicking was reported as a result.Patient experienced 'instability' in (b)(6) 2022.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and instability involving a mrh axle was reported.The event of crack/fracture was confirmed through evaluation of the returned device.Instability was not confirmed.Method & results: device evaluation and results: visual inspection indicated the axle was returned in the fractured condition.Damage consistent with the explantation process.Post fracture abrasion was observed on the axle fracture surfaces indicating the axle fractured in fatigue with the fracture initiating on the rounded surface and propagating toward the notch.Mar not performed as a visual inspection did not indicate the event was as a result of a material integrity issue.Clinician review: no medical records were received for review with a clinical consultant.Device 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.Conclusion: visual inspection indicated the axle was returned in the fractured condition.Damage consistent with the explantation process.Post fracture abrasion was observed on the axle fracture surfaces indicating the axle fractured in fatigue with the fracture initiating on the rounded surface and propagating toward the notch.Mar not performed as a visual inspection did not indicate the event was as a result of a material integrity issue.Further information such as operative reports, progress notes and x-rays are required to fully investigate the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRH AXLE
• 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: 15436364
• Report Number: 0002249697-2022-01358
• Device Sequence Number: 5568997
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 01/31/2019
• Device Model Number: 6481-2-120
• Device Catalogue Number: 64812120
• Device Lot Number: CTD2572
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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 Sex: Unknown