MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 RIGHT; PRSTHSIS,KNEE,PTELLOFMROTIBL,SMI-CNSTRND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	71420186
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to increasing pain.No delay to procedure was reported.
Additional Manufacturer Narrative
The associated genesis ii cmt tibial baseplate, genesis ii oxinium femoral component and legion cr high flexion insert were not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation noted that without the medical documents and/or x-rays, the root cause of the reported pain cannot be definitively concluded.However, based on the surgeon¿s revision op notes the pain was likely due to the lack of adherence of the prosthesis to the cement which would indicate aseptic loosening.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 5 RIGHT
• Common Device Name: PRSTHSIS,KNEE,PTELLOFMROTIBL,SMI-CNSTRND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348200
• Report Number: 1020279-2019-00629
• Device Sequence Number: 1599193
• Product Code: JWH
• UDI-Device Identifier: 03596010206350
• UDI-Public: 03596010206350
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 71420186
• Device Lot Number: 16MM05535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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: Other; Required Intervention
• Patient Age: 48 YR