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

Catalog Number 64812120

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/03/2018

Event Type  Injury  

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.The following devices were also listed in this report: mrhk bumper insert - neutral; cat#64812130; lot#ldj174.Mrhk femoral bushing; cat#64812110; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's left total distal femur was revised after patient complaint of pain.Intra-operatively, the axle was found to be broken.No other cause or contributor to pain was reported.

Event Description

It was reported that the patient's left total distal femur was revised after patient complaint of pain.Intra-operatively, the axle was found to be broken.No other cause or contributor to pain was reported.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an mhr axle was reported.The event was confirmed through visual inspection of the device.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019.This inspection indicated: the returned device parts were examined with the aid of a stereo microscope at magnifications up to 50x.Burnishing was observed in the central portion of the mrh axle.The fracture location of the mrh axel isadjacent to the lot code.Post fracture abrasion obscures the fracture origin.Beach marks are visible and the approximate direction of fracture propagation is shown based on macro fractures observed.Dimensional & functional inspection: not performed as the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis: a material analysis has been performed.The report concluded: the mrh axel fractured in fatigue with the fracture initiating at or near the laser mark.Eds analysis showed the mrh axel to be made of a co-cr-mo alloy consistent with the astm f1537 alloy material.Burnishing was observed in the central portion on the mrh axle¿s outer surface.Explanation and in-service damage were observed on the mrhk bumper and the mrhk bushing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: MRH AXLE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8204649
• MDR Text Key: 131701733
• Report Number: 0002249697-2018-04189
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• Combination Product (y/n): N
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 64812120
• Device Lot Number: CTD2513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 142