MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 15; PRSTHSIS,KNEE,PATELLOFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMER

Catalog Number	71421511
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right tibial baseplate and the ps tibial insert were revised due to pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the attached photos does show significant wear on these devices.The devices were manufactured in 2008.A clinical evaluation was conducted and this case reports that a revision surgery was performed due to pain.The initial implantation occurred 10 years prior to the revision.During the revision the right tibial baseplate and ps tibial insert was revised.Two undated x-rays were provided and the components appear well positioned with maybe some radiolucency around the femoral component but can¿t be confirmed if loosening without the revision report.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information 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 pain cannot be determined.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.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.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 15
• Common Device Name: PRSTHSIS,KNEE,PATELLOFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8206209
• Report Number: 1020279-2018-02953
• Device Sequence Number: 16619508
• Product Code: JWH
• UDI-Device Identifier: 03596010492937
• UDI-Public: 03596010492937
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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 Expiration Date: 02/09/2018
• Device Catalogue Number: 71421511
• Device Lot Number: 08AT16690
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 03/27/2019
• 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