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

Model Number 6481-1-100

Device Problems Fracture (1260); Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

Patient Problem Ambulation Difficulties (2544)

Event Date 03/23/2022

Event Type  Injury  

Event Description

The following was reported: "patient presented on (b)(6) 2022 orthopaedics clinic outpatient clinic for second opinion.Diagnosis by ct, scintigraphy and x-ray.Loosening knee tep left with pathological mobility knee left with fracture of femoral condyle (stryker revision prosthesis).Revision surgery (b)(6) 2023 with explantation femoral shield and mobile parts tibial, extensive synovectomy, palacosspac insertion knee left.Condition after tibial plateau fracture 2012 left, condition after knee tep implantation 2013, condition after knee tep replacement 2016, condition after knee tep replacement 2018, condition after implantation retropatellar knee replacement 2020." additional requests for further information have been submitted.

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.

Event Description

The following was reported: "patient presented on (b)(6) 2022 orthopaedics clinic outpatient clinic for second opinion.Diagnosis by ct, scintigraphy and x-ray.Loosening knee tep left with pathological mobility knee left with fracture of femoral condyle (stryker revision prosthesis).Revision surgery on (b)(6) 2023 with explantation femoral shield and mobile parts tibial, extensive synovectomy, palacosspac insertion knee left.Condition after tibial plateau fracture 2012 left, condition after knee tep implantation 2013, condition after knee tep replacement 2016, condition after knee tep replacement 2018, condition after implantation retropatellar knee replacement 2020.".

Manufacturer Narrative

Reported event: an event regarding loosening and fracture involving a mrh femoral component was reported.The event was confirmed.Method & results: device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as no devices were returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "this patient underwent a total knee arthroplasty following a tibial plateau fracture in 2012.The patient had several revisions and ultimately was revised with a rotating hinge prosthesis.Subsequently, the rotating hinge prosthesis loosened and there was a fracture of the femoral condyle of the prosthesis.The patient was revised using a bolus of cement on the femoral side articulating with the tibial implant.I can confirm that the patient had a rotating hinge prosthesis and eventually had an arthroplasty with a bolus of cement articulating with the tibial insert.I was able to review x-rays.The root cause of this event cannot be determined with certainty.The causes of loosening of a rotating hinge implant with fracture of the femoral condyle are multifactorial including surgical technique factors, patient factors including activity level and bmi and implant factors." device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the patient was revised due loosening and fracture femoral component.The event was confirmed via evaluation of medical records by a clinical consultant.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.A review of the provided medical records by a clinical consultant stated the following comment: "this patient underwent a total knee arthroplasty following a tibial plateau fracture in 2012.The patient had several revisions and ultimately was revised with a rotating hinge prosthesis.Subsequently, the rotating hinge prosthesis loosened and there was a fracture of the femoral condyle of the prosthesis.The patient was revised using a bolus of cement on the femoral side articulating with the tibial implant.I can confirm that the patient had a rotating hinge prosthesis and eventually had an arthroplasty with a bolus of cement articulating with the tibial insert.I was able to review x-rays.The root cause of this event cannot be determined with certainty.The causes of loosening of a rotating hinge implant with fracture of the femoral condyle are multifactorial including surgical technique factors, patient factors including activity level and bmi and implant factors.".

• Brand Name: MRH KNEE FEM XS LFT
• 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 NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16642213
• MDR Text Key: 312284473
• Report Number: 0002249697-2023-00327
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045109
• UDI-Public: 07613327045109
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 6481-1-100
• Device Catalogue Number: 64811100
• Device Lot Number: ANF3F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 100 KG