MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PRSTHSIS,KNEE,PATLLFMRTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMER

Catalog Number	71420168
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to aseptic loosening of the left total knee arthroplasty.
Additional Manufacturer Narrative
The associated legion ps oxinium femoral component, genesis ii patellar component, genesis ii cmt tibial baseplate and legion ps high flexion insert were not returned for evaluation.The devices were manufactured in 2013 and 2014.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted that based on the available information, the root cause for the instability and loosening cannot be concluded.However, the scar tissue, patella looseness and the ¿flexion contractures¿ could have contributed to this patient¿s issues.No further up-dated patient information has been submitted for review.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• Common Device Name: PRSTHSIS,KNEE,PATLLFMRTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7922098
• Report Number: 1020279-2018-01907
• Device Sequence Number: 1654242
• Product Code: JWH
• UDI-Device Identifier: 03596010206275
• UDI-Public: 03596010206275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 01/12/2024
• Device Catalogue Number: 71420168
• Device Lot Number: 14AM10407
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 58 YR