MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PRSTHSSKNEEPTLLFMRTIBLSMICNSTRINDCMNTDPLYMRETALPOLYMR

Model Number	71420574
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to feeling of unwillingness and loosening of the patella.Surgeon does not blame the devices.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event 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 and concluded this failure mode has been identified.Our clinical/medical team noted: it was reported that a revision surgery was performed due to feeling of unwillingness and loosening of the patella.It was also noted the surgeon does not blame the devices.However, to date no medical records have been received.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event of medical/clinical records being received, the clinical task will be re-opened and a thorough assessment will be rendered 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 RESURF PAT 29MM
• Common Device Name: PRSTHSSKNEEPTLLFMRTIBLSMICNSTRINDCMNTDPLYMRETALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9721673
• Report Number: 1020279-2020-00620
• Device Sequence Number: 14041717
• Product Code: JWH
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: Health Professional
• Device Model Number: 71420574
• Device Catalogue Number: 71420574
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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