MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420566
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2014, a gns ii biconvex pat 23mm loosened and worn.The adverse event was addressed with a revision surgery on (b)(6) 2021.The condition of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a patella revision was performed approximately 7 years post implantation due to a loosened and worn component.Reportedly, the ¿surgeon says the devices were not defective¿.It was communicated that the requested clinical documentation was not available for inclusion in the medical investigation.Therefore, the clinical root cause of the reported event could not be definitively concluded.The patient impact beyond the loosening and wear which was reported could not be further assessed.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GNS II BICONVEX PAT 23MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11730225
• Report Number: 1020279-2021-03532
• Device Sequence Number: 4026238
• Product Code: JWH
• UDI-Device Identifier: 03596010208255
• UDI-Public: 03596010208255
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

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: 05/06/2024
• Device Model Number: 71420566
• Device Catalogue Number: 71420566
• Device Lot Number: 14EM07936
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 09/06/2021
• 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; Other; Required Intervention