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

Model Number	6481-1-120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
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
Fracture of implanted mrh femoral posteriolateral metall condyle.
Event or Problem Description
Fracture of implanted mrh femoral posteriolateral metall condyle.
Additional Manufacturer Narrative
An event regarding fracture involving an mrh femoral component was reported.The event was confirmed through medical review.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted 64811120 , mrh femoral component.From the photographs provided there is evidence of a crack/fracture of the condyle.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: "regarding the referenced pi, this case represents a female patient whose date of birth is march 10, 1972, and who is described as 186- centimeters tall, weighing 92 kilograms.The source of this case is germany.The event description states, ¿fracture of implanted mrh femoral posterolateral metal condyle¿.On (b)(6) 2008 a primary stryker mrh total knee replacement of the left knee was performed for a diagnosis of ¿status-post open fracture lower leg and femoral fracture¿.A brief, translated operative report describes general anesthesia and the use of a tourniquet.The note states, ¿¿ most severe ¿ post-traumatic gonarthrosis ¿ status-post open fracture ¿ several years ago ¿ severe ligament instability ¿¿, and ¿¿ mrh femoral component medium, 15/80 cementless stem, mrh tibial component medium, 23/80 cementless stem, 13mm polyethylene insert on a metal rotation platform, axis, hybrid cement technique¿.No patella resurfacing was described.Uncomplicated surgery is noted.On (b)(6) 2019 a revision of the left total knee was performed for which no operative report is available.Undated, unlabeled intraoperative color photographs of a left total knee arthroplasty with a displaced fracture of the posterolateral femoral condyle of the femoral component with subluxation of the left hinged total knee arthroplasty is noted.Two undated color photographs of the explanted tibial and femoral components, axel, polyethylene insert, and femoral fracture fragment are noted.No femoral or tibial stems are included.X-ray printouts include an undated ap and lateral of the left knee demonstrating an mrh total knee arthroplasty with no patellar resurfacing, lateral subluxation of the left tibial component, and the proximal femur and distal tibial stems are not visualized.In this young, obese patient with a constrained total knee arthroplasty in situ for eleven and two-thirds years, fracture of the posterolateral femoral condyle likely occurred as an inevitable fatigue fracture in this constrained salvage surgery.No clinical or past medical history, no examination of the explanted components, and no revision operative report are available for review.Examination of the explanted components and the fracture surfaces would confirm this mechanism and rule out factors associated with implant manufacturing or materials as having contributed to this clinical event." device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusions: the investigation concluded that 'fracture of the posterolateral femoral condyle likely occurred as an inevitable fatigue fracture in this constrained salvage surgery.' the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays , device details and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: MRH KNEE FEM M LFT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9568181
• Report Number: 0002249697-2020-00057
• Device Sequence Number: 546773
• Product Code: KRO
• UDI-Device Identifier: 07613327045154
• UDI-Public: 07613327045154
• Combination Product (Y/N): N
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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 Model Number: 6481-1-120
• Device Catalogue Number: 64811120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 92