MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GNS II CMT TIB SIZE 6 {} LEFT; PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	71420170
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: attorney.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to stiffness.
Additional Manufacturer Narrative
The associated genesis ii resurfacing patellar component, genesis ii oxinium femoral component, genesis ii tibial baseplate and legion cr high flexion insert were not returned for evaluation.A clinical analysis noted that without the explant, physical therapy records, or radiographs, the information provided is insufficient to determine the root cause of left knee stiffness.However, the healing process of the procedure implanting the smith and nephew device, poor rehab, or inflammatory cannot be ruled out and not due to the smith and nephew device itself.In addition, the reported of the patient¿s fall as well as the patient¿s body habitus cannot be ruled out as possible contributing factors.The patients¿ left knee flexion improved from 0-70 prior to the revision to about 0-110° post revision.The future impact to the patient beyond the revision cannot be determined.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 6 {} LEFT
• Common Device Name: PRSTHSIS,KNEE,PATLLFMORTIBIL,SMICONSTRAIND,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7924075
• Report Number: 1020279-2018-01902
• Device Sequence Number: 19243346
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• 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: 2016
• 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): 04/05/2019

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: No Information
• Device Expiration Date: 07/03/2017
• Device Catalogue Number: 71420170
• Device Lot Number: 15KM03838
• 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: 04/05/2019
• 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: 64 YR