MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHE, KNEE, PATELLOFEMOR, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	71420568
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain due to an overstuffed joint and a lot of scar tissue.A revision surgery was performed ,revised poly and the patella taking out a biconvex and implanting a 38mm oval patella.There was no implant failure.
Additional Manufacturer Narrative
The devices, intended for use in treatment, was not returned for evaluation and the reported events could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use document for this failure mode was conducted.Some potential probable causes of this event could include infection, inflammation/synovitis, revision, non-implant/explant surgery and patient pain.Our clinical medical team noted: no clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.However, it was reported that the patient required a revision ¿due to an overstuffed joint and a lot of scar tissue¿, and ¿there was no implant failure¿.The patient impact beyond the reported symptoms, the overstuffed joint, and revision could not be assessed.Should relevant patient specific clinical documentation become available, the medical investigation may be re-evaluated at that time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROSTHE, KNEE, PATELLOFEMOR, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9588738
• Report Number: 1020279-2020-00276
• Device Sequence Number: 2499901
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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 Model Number: 71420568
• Device Catalogue Number: 71420568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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