MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM M/L M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813310
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to wear of the poly component.Possible cause or contributor for wear not reported.Patient's activity level is unknown.Patient was revised to poly component of the same catalog number.Rep reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding damage involving a mrh insert reported.The event was confirmed by mar review.Method & results: - product evaluation and results: - visual inspection: the femoral bushings and the bumper insert show damage and material loss on both the femoral bushings and the bumper insert are consistent with contact against a hard object.Discoloration of the femoral bushings and bumper insert are consistent with synovial fluid absorption.Delamination also occurred on the femoral bushings which is a common damage mode of uhmwpe.Significant wear was observed on the proximal portion of the bumper insert shows wear resulted in the loss of material which potentially enabled the femoral component to contact the tibial component.-dimensional inspection: not performed as the device was returned in damage condition.-functional inspection: not performed as the device was returned in damage condition.-material analysis: delamination, burnishing, scratching and third-body indentations are present on the insert.These are common damage modes of uhmwpe.Damage was observed on the femoral bushings and bumper insert consistent with contact against a hard object.Significant wear was observed on the bumper insert.Damage was observed on the axle and tibial rotating component, consistent with in-service use.Damage on the tibial rotating component likely occurred from contact with the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: a complaint history review could not be performed as lot code are unknown.Conclusions: it was reported that the patient was revised due to wear of the poly component.The event was confirmed by mar review.Investigation concluded that scratching and third-body indentations are present on the insert.These are common damage modes of uhmwpe.Damage was observed on the femoral bushings and bumper insert consistent with contact against a hard object.Significant wear was observed on the bumper insert.Damage was observed on the axle and tibial rotating component, consistent with in-service use.Damage on the tibial rotating component likely occurred from contact with the femoral component.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.
Event or Problem Description
It was reported that the patient's left knee was revised due to wear of the poly component.Possible cause or contributor for wear not reported.Patient's activity level is unknown.Patient was revised to poly component of the same catalog number.Rep reported that no further information will be available.

• Brand Name: MRHK TIB INS 10MM M/L M2/L2
• 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: 8627584
• Report Number: 0002249697-2019-02021
• Device Sequence Number: 2308931
• Product Code: KRO
• UDI-Device Identifier: 07613327043822
• UDI-Public: 07613327043822
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/16/2019

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 Expiration Date: 12/01/2015
• Device Catalogue Number: 64813310
• Device Lot Number: LCD637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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: 25 YR