MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PRSTHEIS,KNEE,PATLLOFEMOROTIBL,SMICONSTRAIND,CMENTED, POLYMER/METAL/POLYMER

Catalog Number	71420168
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a regional three phase bone scan of the knees was performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.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.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 5 {} LEFT
• Common Device Name: PRSTHEIS,KNEE,PATLLOFEMOROTIBL,SMICONSTRAIND,CMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7949871
• Report Number: 1020279-2018-02150
• Device Sequence Number: 428436
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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: Other
• Patient Age: 61 YR