MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK FEMORAL BUSHING; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64812110
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
First revision to distal femur due to mrh knee femoral bushing p.E.Wear, + broken metallic mechanical failure of lateral femoral condyle.
Additional Manufacturer Narrative
An event regarding wear involving a mrh bushing was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this patient underwent what was most likely a tumor resection with implantation of a distal femoral and proximal tibial replacement with cemented stems.Approximately nine years after implantation the patient developed polyethylene wear and a fracture of the femoral component.Subsequently the patient developed aseptic loosening.I can confirm that the patient had a procedure with a tumor type prosthesis since i was able to see the x-rays.The x-rays are compatible with loosening of the femoral component.I cannot confirm any of the other surgeries because i have no documentation such as office notes, operation notes or sequential revision x-rays.The root cause of these events cannot be determined with certainty.The root causes of polyethylene wear are multifactorial including surgical factors such as technique, ligament balancing and restoration of proper kinematics.Patient factors include activity level and bmi.Implant factors can also contribute.In this case the use of a mega prosthesis in a relatively young patient can lead to polyethylene wear.Causes of implant fracture are also multifactorial including surgical technique factors with proper support for the implant and cementing technique as well as ligament balancing and restoration of kinematics.Patient activity level and bmi can also contribute.The removed should be submitted to stryker engineers for examination and evaluation to determine if any defects were present in the implant.Loosening of a cemented mega prosthesis is not unusual.The use of a heavy implant with cemented medium length stems can eventually result in loosening depending on the alignment, cement technique and patient activity level and bmi." product history review: not performed as the lot number is unknown.Complaint history review: not performed as the lot number is unknown.Conclusions: it was reported that the patient was revised due to fracture of the femoral component and bushing p.E wear.A review of the provided medical records by a clinical consultant indicated: "this patient underwent what was most likely a tumor resection with implantation of a distal femoral and proximal tibial replacement with cemented stems.Approximately nine years after implantation the patient developed polyethylene wear and a fracture of the femoral component.Subsequently the patient developed aseptic loosening.I can confirm that the patient had a procedure with a tumor type prosthesis since i was able to see the x-rays.The x-rays are compatible with loosening of the femoral component.I cannot confirm any of the other surgeries because i have no documentation such as office notes, operation notes or sequential revision x-rays.The root cause of these events cannot be determined with certainty.[.] loosening of a cemented mega prosthesis is not unusual.The use of a heavy implant with cemented medium length stems can eventually result in loosening depending on the alignment, cement technique and patient activity level and bmi." (no medical records were received pertaining to this loosening event that occurred in 2020) 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 or Problem Description
First revision to distal femur due to mrh knee femoral bushing p.E.Wear, + broken metallic mechanical failure of lateral femoral condyle.

• Brand Name: MRHK FEMORAL BUSHING
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17422641
• Report Number: 0002249697-2023-00855
• Device Sequence Number: 20725894
• Product Code: KRO
• UDI-Device Identifier: 07613327045246
• UDI-Public: 07613327045246
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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 Catalogue Number: 64812110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White