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	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: mrh axle broken in the middle.No violence/no trauma - according to the doctor, the axle broke without any external influence when the knee was bent.Patient has presented himself at the consultation.Loud noise when bending.According to the patient, there was only a popping sound.The now defective system was installed in another clinic in 2016.Here today only the revision procedure.
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 other similar events for the lot referenced.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
The following was reported: mrh axle broken in the middle.No violence/no trauma - according to the doctor, the axle broke without any external influence when the knee was bent.Patient has presented himself at the consultation.Loud noise when bending.According to the patient, there was only a popping sound.The now defective system was installed in another clinic in 2016.Here today only the revision procedure.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh axle was reported.The event was confirmed via evaluation of the returned device.Method & results: device evaluation and results: visual inspection: visual inspection indicated the axle was returned in fractured condition.Material analysis: a material analysis has not been performed on this device as material analyses have previously been performed on similarly fractured mrh axle devices.The previous material analyses have concluded that the devices fractured in fatigue with fracture initiated near the location of laser etching on the component.Additionally, in those previous cases, the locations and heights of the v shield, lot code and catalogue number laser markings did not meet the drawing requirements.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 has been 1 other similar event for the reported lot.Conclusion: it was reported that the patient was revised due to fracture of the mrh axle.Visual inspection indicated the axle was returned in fractured condition.A material analysis has not been performed on this device as material analyses have previously been performed on similarly fractured mrh axle devices.The previous material analyses have concluded that the devices fractured in fatigue with fracture initiated near the location of laser etching on the component.Additionally, in those previous cases, the locations and heights of the v shield, lot code and catalogue number laser markings did not meet the drawing requirements.The subject device is in scope of nc which was issued on 17-apr-2024 to investigate the discrepancies in the heights and locations of the laser markings.A review of the hra associated with nc indicates the following in section 3: "as per this investigation it is shown that nonconforming parts were deemed to be capable of meeting product expectations under laboratory testing and some of the early failures seen in the complaints may be a result of significant extenuating factors.It is also understood that when overloaded or fatigued, fractures of the axle would occur, initiating at the superior surface of the axle, regardless of the positioning of the laser etching, as supported by the reports of fracture seen in the krh axles." refer to the nc record for further details.Further information such as operative reports, progress notes and pre- and post-operative 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: 19130566
• Report Number: 0002249697-2024-00618
• Device Sequence Number: 17867545
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 04/30/2021
• Device Catalogue Number: 64812120
• Device Lot Number: CTD8666
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2016
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 100 KG