MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 18; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	71421519
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/20/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to right knee instability status post total knee replacement.Tibial component, tibial baseplate and poly insert were removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and although it was reported that an mua was preformed no procedure documentation was provided for review.C-0224378, c-0224379, c-0224380: details regarding the patient¿s weight-bearing status, bone quality, and trauma history have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported instability cannot be determined however, during the revision it was found that the polyethylene was dissociated from the base plate, and this is likely a contributing factor to the instability.The patient impact beyond the revision itself cannot be concluded.C-0224381: based on the information provided, the ¿right knee stiffness¿ experienced by the patient was likely a normal progression of the post-operative healing phase and not a failure of the smith and nephew device.Information around the patient¿s post-operative rehabilitation prior to this mua was not provided.No further medical assessment is possible at this time based on the information provided.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.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: GII PS HI FLEX ISRT SZ 5-6 18
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8157023
• Report Number: 1020279-2018-02770
• Device Sequence Number: 2165977
• Product Code: JWH
• UDI-Device Identifier: 03596010493835
• UDI-Public: 03596010493835
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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 Expiration Date: 10/28/2016
• Device Catalogue Number: 71421519
• Device Lot Number: 06KM11000
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 06/10/2019
• 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: 52 YR