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

Model Number	6481-1-111
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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
Protheos distributor reported that: "mrh femoral housing failure" first implantation (b)(6) 2013, second intervention (b)(6) 2014, revision surgery: (b)(6) 2019.
Additional Manufacturer Narrative
Additional information: implant date.An event regarding crack/fracture was reported involving mrh femoral component.The event was confirmed by attached mar.Method & results:  device evaluation and results: visual inspection of attached images was performed and stated that.The femoral component and stem were returned in the assembled condition.The femoral bone cement was observed on the proximal surface of the femoral component and stem.Scratching was observed on the articulating surface of the femoral component.The fractured condyle was examined further using a scanning electron microscope (sem).Ma the fractured condyle was examined further using a scanning electron microscope (sem).Fatigue striations were observed on the fracture surface near the articulating surface indicating the component fractured in fatigue.The dimple morphology near the proximal surface indicates that final fracture occurred in overload.Energy dispersive spectroscopy (eds) analysis was performed on the femoral component, tibial rotating component, and axle.The results from the eds spectrum are shown in table 1.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.Clinician review: no medical records were received for review with a clinical consultant device history review: product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusion: it was reported that - visual inspection of attached images was performed and stated that.The femoral component and stem were returned in the assembled condition.The femoral bone cement was observed on the proximal surface of the femoral component and stem.Scratching was observed on the articulating surface of the femoral component.The fractured condyle was examined further using a scanning electron microscope (sem).Ma the fractured condyle was examined further using a scanning electron microscope (sem).Fatigue striations were observed on the fracture surface near the articulating surface indicating the component fractured in fatigue.The dimple morphology near the proximal surface indicates that final fracture occurred in overload.Energy dispersive spectroscopy (eds) analysis was performed on the femoral component, tibial rotating component, and axle.The results from the eds spectrum are shown in table 1.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.The exact cause of the event could not be determined because insufficient information was provided.  additional information including device details, operative reports, progress notes and x-rays to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Protheos distributor reported that : "mrh femoral housing failure" first implantation (b)(6) 2013.Second intervention (b)(6) 2014.Revision surgery : (b)(6) 2019.

• Brand Name: MRH KNEE FEM S RGT
• 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: 9588307
• Report Number: 0002249697-2020-00086
• Device Sequence Number: 3604160
• Product Code: KRO
• UDI-Device Identifier: 07613327045147
• UDI-Public: 07613327045147
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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 Expiration Date: 03/31/2019
• Device Model Number: 6481-1-111
• Device Catalogue Number: 64811111
• Device Lot Number: EHH7T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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: 46 YR