MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT 3 DEGREES; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64812133
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/30/2019
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
It was reported that patient's right distal femur was revised due to wear and debris from the insert and sleeve.Surgeon has requested that an elemental analysis be performed on the devices, which will be returned.
Event or Problem Description
It was reported that patient's right distal femur was revised due to wear and debris from the insert and sleeve.Surgeon has requested that an elemental analysis be performed on the devices, which will be returned.
Additional Manufacturer Narrative
An event regarding wear and debris from the insert and sleeve involving a mrh bumper insert was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.It was reported that the patient was revised due to wear and debris from the insert and sleeve.Visual inspection of the device indicated that no indication to suggest a product non-conformity or unanticipated hazard.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: MRHK BUMPER INSERT 3 DEGREES
• 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: 9238822
• Report Number: 0002249697-2019-03610
• Device Sequence Number: 19243929
• Product Code: KRO
• UDI-Device Identifier: 07613327045277
• UDI-Public: 07613327045277
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• 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): 12/26/2019

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 Catalogue Number: 64812133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/26/2019
• 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: 43 YR
• Patient Weight: 52