MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIBIAL SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64812140
Medical Device Problem Code	Naturally Worn (2988)
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.
Additional Manufacturer Narrative
An event regarding wear involving a mrh sleeve was reported.The event was not confirmed.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report mar, dated 31-oct-2019.The devices were examined with the aid of a stereo microscope at magnifications up to 50x.This inspection indicated that damage consistent with the explantation process was observed.Synovial fluid absorption was observed.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: based on the ma review, damage consistent with the explantation process was observed.Synovial fluid absorption was observed.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.No excessive wear was noticed on the mrh sleeve.Thus, the failure mode could not be confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, and additional serial dated x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patients 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.

• Brand Name: MRHK TIBIAL SLEEVE
• 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: 9238825
• Report Number: 0002249697-2019-03611
• Device Sequence Number: 163631
• Product Code: KRO
• UDI-Device Identifier: 07613327045284
• UDI-Public: 07613327045284
• 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: 64812140
• 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