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

Catalog Number	64812120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2023
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 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.
Event or Problem Description
Revision of distal femur gmrs, discovered broken axel during surgery.
Event or Problem Description
Revision of distal femur gmrs, discovered broken axel during surgery.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh axle was reported.The event of crack/fracture was confirmed.Method & results: -device evaluation and results: visual inspection: review of mrhk axle, catalogue number 6481-2-120, lot code ctd12702 confirmed fracture of the device.Material analysis: characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrhk axle.The device fractured in fatigue and the fracture initiated near the location of laser etching on the component.The locations and heights of the v shield, lot code and catalogue number laser markings do not meet the drawing requirements.Yellow discolouration consistent with synovial fluid absorption was observed on the femoral bushings.-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: nc was issued to investigate the discrepancies in the heights and locations of the laser markings.Conclusion: the reported event was confirmed.The device fractured in fatigue and the fracture initiated near the location of laser etching on the component.The locations and heights of the v shield, lot code and catalogue number laser markings do not meet the drawing requirements.Nc was issued on 17-apr-2024 to investigate the discrepancies in the heights and locations of the laser markings.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Correction: d4.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18453032
• Report Number: 0002249697-2024-00035
• Device Sequence Number: 20565730
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• 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: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 02/28/2022
• Device Catalogue Number: 64812120
• Device Lot Number: CTD12702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2017
• 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: 70 YR
• Patient Sex: Male