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

Model Number	6481-1-120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Axle break.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh axle was reported.The event was confirmed through material analysis evaluation of the returned device.Method & results: -device evaluation and results: the axle was returned in the fractured condition.Damage consistent with the explantation process and/or post fracture abrasion was observed on the axle fracture surfaces.The fracture initiated on the rounded surface and propagated toward the notch.A material analysis has been performed.The report concluded: the returned axle had fractured in fatigue; with the fracture initiating on the rounded surface and propagating toward the notch.Eds showed that the axle base chemistry was consistent with an astm f1537 alloy which was consistent with the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-device history review: not performed as the lot information was unknown.-complaint history review: not performed as the lot information was unknown.Conclusion: the material analysis report of the returned device indicated: the returned axle had fractured in fatigue; with the fracture initiating on the rounded surface and propagating toward the notch.Eds showed that the axle base chemistry was consistent with an astm f1537 alloy which was consistent with the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event cannot be determined as insufficient information was provided.Further information such as device lot information, 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.
Event or Problem Description
Axle break.

• Brand Name: MRH KNEE FEM M LFT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10257882
• Report Number: 0002249697-2020-01408
• Device Sequence Number: 2698122
• Product Code: KRO
• UDI-Device Identifier: 07613327045154
• UDI-Public: 07613327045154
• Combination Product (Y/N): N
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 03/31/2020
• Device Model Number: 6481-1-120
• Device Catalogue Number: 64811120
• Device Lot Number: CTD7%46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 120