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

Model Number	6481-1-100
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.".
Additional 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.".
Additional Manufacturer Narrative
Reported event: an event regarding loosening and fracture involving a mrh femoral component was reported.The event was confirmed via medical review and visual inspection of the returned device.Method & results: device evaluation and results: visual inspection: shows a secondary electron image of the fracture origin, no evidence of shrinkage or heavy porosity was observed near this region, or any fracture surfaces examined.The secondary electron microscope image shows a representative area of the propagation region of the fracture surface, showing fatigue striations, indicating the fracture propagated in fatigue.Energy dispersive spectroscopy (eds) was performed on the base material of the fracture surface of the femoral component to characterise its material composition.Elemental constituents included cobalt, chromium, molybdenum and silicon which are consistent with cobalt, chromium and molybdenum casting alloy [3].Review of the mrhk femoral component, catalogue # 6481-1-100, lot code anf3f confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the lateral condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the components.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.Visual inspection: shows a secondary electron image of the fracture origin, no evidence of shrinkage or heavy porosity was observed near this region, or any fracture surfaces examined.The secondary electron microscope image shows a representative area of the propagation region of the fracture surface, showing fatigue striations, indicating the fracture propagated in fatigue.Energy dispersive spectroscopy (eds) was performed on the base material of the fracture surface of the femoral component to characterise its material composition.Elemental constituents included cobalt, chromium, molybdenum and silicon which are consistent with cobalt, chromium and molybdenum casting alloy [3].Review of the mrhk femoral component, catalogue # 6481-1-100, lot code anf3f confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the lateral condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the components.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.".
Event or Problem 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.".

• Brand Name: MRH KNEE FEM XS LFT
• 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 NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16642213
• Report Number: 0002249697-2023-00327
• Device Sequence Number: 6120437
• Product Code: KRO
• UDI-Device Identifier: 07613327045109
• UDI-Public: 07613327045109
• 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: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2021
• Device Model Number: 6481-1-100
• Device Catalogue Number: 64811100
• Device Lot Number: ANF3F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/19/2024
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 07/14/2023; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2016
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 100 KG