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

Model Number 6481-1-111

Device Problem Fracture (1260)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.Device not returned.

Event Description

Fractured right mrh femur component.The initial surgery took place on (b)(6) 2007.It has already been revised on (b)(6) 2011 and (b)(6) 2015.Now the third revision will be performed.

Event Description

Fractured right mrh femur component.The initial surgery took place on (b)(6) 2007.It has already been revised on (b)(6) 2011 and (b)(6) 2015.Now the third revision will be performed.

Manufacturer Narrative

An event regarding crack/fracture involving a mrh femoral component was reported.The event of crack/fracture was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: resorption of a local bone graft at the interface of lateral femoral condylar mrh flange and local femoral bone has resulted in loss of bone support with fatigue accumulation in the lateral mrh and ultimately a femoral mrh device fracture at exactly the location of peak overload requiring a third revision with quite likely a femoral gmrs device and cone augment.No details or results of this third revision procedure are known at this time.Does the review identify any procedural related factors that contributed to the event? - resorption of bone graft at the interface of lateral femoral condylar mrh flange contributing to a local overload condition.Does the review identify any patient related factors that contributed to the event? - none evident, partly due to lack of relevant information.Does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices, consistent with the reported failure mode.-device history review: all 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.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: resorption of a local bone graft at the interface of lateral femoral condylar mrh flange and local femoral bone has resulted in loss of bone support with fatigue accumulation in the lateral mrh and ultimately a femoral mrh device fracture at exactly the location of peak overload requiring a third revision with quite likely a femoral gmrs device and cone augment.No details or results of this third revision procedure are known at this time.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRH KNEE FEM S RGT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10507788
• MDR Text Key: 206173336
• Report Number: 0002249697-2020-01817
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045147
• UDI-Public: 07613327045147
• Combination Product (y/n): N
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 6481-1-111
• Device Catalogue Number: 64811111
• Device Lot Number: ELN6P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR