MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER

Model Number	71420568
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
This revision surgery was performed due to disassociation and a feeling of wrongness caused by patient's fall.Patella was explanted.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical analysis indicated it was reported that revision surgery was performed due to disassociation and a feeling of wrongness caused by the patient's fall.It is noted the primary surgery was performed on (b)(6) 2018 and on (b)(6) 2019, the patella component seemed to be disassociated and a revision was done.It is also noted the doctor's comment: this revision was not caused by the device but the patient's fall.No surgical reports or medical imaging was provided.No further clinical assessment is warranted at this time.In the event additional medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history for the provided part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions for use document were reviewed.Factors and/or some potential probable causes that could include but not limited to abnormal loading of limb, fit/sizing, post-operative healing issue, traumatic injury, and unclear user instructions.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROSTHESISKNEEPATELLOFEMOROTIBIALSEMICONSTRAINEDCEMENTEDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9383469
• Report Number: 1020279-2019-04176
• Device Sequence Number: 2026297
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: 71420568
• Device Catalogue Number: 71420568
• Device Lot Number: 17JM09820
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 09/09/2020
• 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