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

Model Number 6481-2-120

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

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.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.

Event Description

The gmrs axle snapped in half while implanted in the patient.No other components were damaged.There was no accident or injury leading to the event.The patient experienced clicking in his knee and went in for imaging.Ct revealed a broken axle and a revision surgery was required.

Event Description

The gmrs axle snapped in half while implanted in the patient.No other components were damaged.There was no accident or injury leading to the event.The patient experienced clicking in his knee and went in for imaging.Ct revealed a broken axle and a revision surgery was required.

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: the device was not returned however photos were provided for review.Visual inspection indicated the axle fractured in half.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.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: the device was not returned however photos were provided for review.Visual inspection indicated the axle fractured in half.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
• Type of Device: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16143528
• MDR Text Key: 307153805
• Report Number: 0002249697-2023-00028
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 6481-2-120
• Device Catalogue Number: 64812120
• Device Lot Number: CTD2918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male