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

Catalog Number 64812133

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/30/2019

Event Type  Injury  

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 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 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.

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
• 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: 9238822
• MDR Text Key: 165560111
• Report Number: 0002249697-2019-03610
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045277
• UDI-Public: 07613327045277
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 52