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

Catalog Number	64812140
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
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 released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding damage involving a mrh sleeve reported.The event was confirmed by mar review.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019 which indicated the tibial sleeve had damage consistent with the explantation process.Discoloration consistent with synovial fluid absorption was observed.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: the tibial sleeve had damage consistent with the explantation process.Discoloration consistent with synovial fluid absorption was observed.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: a review of the product history records could not be performed as lot code are unknown.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 the tibial sleeve showed damage with consistent with the explantation process.Discoloration consistent with synovial fluid absorption was observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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 released by the hospital or surgeon.

• 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: 8627589
• Report Number: 0002249697-2019-02023
• Device Sequence Number: 16686447
• Product Code: KRO
• UDI-Device Identifier: 07613327045284
• UDI-Public: 07613327045284
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 04/29/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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