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

Model Number 6481-2-120

Device Problems Break (1069); Fracture (1260)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 07/24/2022

Event Type  Injury  

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 Description

The customer reported a "broken axle" to the competent authority.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a mrh axle was reported.The event was confirmed via evaluation of device photographs and review of the provided medical records by a clinical consultant.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that all devices were recently explanted.Polyethylene components, the rotating tibial component, and the femoral component have no notable damage.The axle has fractured down the midway point.All devices appear covered in blood.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a modular revision to prosthesis for a malignant tumor at age 39.The approximately nine years later a revision was required because of a fracture of the axle of the tumor prosthesis.A revision was necessitated due to the implant fracturing.I can confirm that the patient underwent a tumor type prosthesis for a malignant tumor since i was able to review the operation report and the x-rays.One of the x-rays show an abnormality which most likely represents the axle extruding from the medial side of the femoral prosthesis.The postop x-rays appear satisfactory (i would assume the documents marked "postop" are of the revision procedure.) the root causes of fracture of an axle within a tumor type prosthesis are multifactorial including surgical technique factors such as proper assembly, etc., patient factors including bmi and activity level, and implant factors such as possible stress fracture, etc.".Product 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.Conclusions: it was reported that the patient was revised due to a fractured axle.The event was confirmed via evaluation of the photographs of the reported devices and via review of the provided medical records by a clinical consultant.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device and additional pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The reviewing clinical consultant indicated that "the root causes of fracture of an axle within a tumor type prosthesis are multifactorial including surgical technique factors such as proper assembly, etc., patient factors including bmi and activity level, and implant factors such as possible stress fracture, etc." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The customer reported a "broken axle" to the competent authority.

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 and review of the provided medical records by a clinical consultant.Method & results: product evaluation and results: visual inspection of the provided photographs indicated that all devices were recently explanted.Polyethylene components, the rotating tibial component, and the femoral component have no notable damage.The axle has fractured down the midway point.A material analysis has been performed.The report concluded: review of mrhk axle, catalog # 6481-2-120, lot code ctd5839 confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrhk axle.The device fractured in fatigue and the fracture initiated at the location of laser etching on the component.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a modular revision to prosthesis for a malignant tumor at age 39.The approximately nine years later a revision was required because of a fracture of the axle of the tumor prosthesis.A revision was necessitated due to the implant fracturing.I can confirm that the patient underwent a tumor type prosthesis for a malignant tumor since i was able to review the operation report and the x-rays.One of the x-rays show an abnormality which most likely represents the axle extruding from the medial side of the femoral prosthesis.The postop x-rays appear satisfactory (i would assume the documents marked "postop" are of the revision procedure.) the root causes of fracture of an axle within a tumor type prosthesis are multifactorial including surgical technique factors such as proper assembly, etc., patient factors including bmi and activity level, and implant factors such as possible stress fracture, etc." product 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.Conclusions: it was reported that the patient was revised due to a fractured axle.Visual inspection indicated that all devices were recently explanted.Polyethylene components, the rotating tibial component, and the femoral component have no notable damage.The axle has fractured down the midway point.A material analysis has been performed.The report concluded: review of mrhk axle, catalog # 6481-2-120, lot code ctd5839 confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrhk axle.The device fractured in fatigue and the fracture initiated at the location of laser etching on the component.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a modular revision to prosthesis for a malignant tumor at age 39.The approximately nine years later a revision was required because of a fracture of the axle of the tumor prosthesis.A revision was necessitated due to the implant fracturing.I can confirm that the patient underwent a tumor type prosthesis for a malignant tumor since i was able to review the operation report and the x-rays.One of the x-rays show an abnormality which most likely represents the axle extruding from the medial side of the femoral prosthesis.The postop x-rays appear satisfactory (i would assume the documents marked "postop" are of the revision procedure.) the root causes of fracture of an axle within a tumor type prosthesis are multifactorial including surgical technique factors such as proper assembly, etc., patient factors including bmi and activity level, and implant factors such as possible stress fracture, etc."no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The customer reported a "broken axle" to the competent authority.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15604778
• MDR Text Key: 301730791
• Report Number: 0002249697-2022-01491
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045253
• UDI-Public: 07613327045253
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 6481-2-120
• Device Catalogue Number: 64812120
• Device Lot Number: CTD5839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 140 KG