MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	71420190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that revision surgery was performed due to patient showed signs of aseptic loosening of his tibial component post tkr.Tibial and patella components were removed.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that, no relevant clinical information has been provided to perform a thorough medical investigation.Per the analysis of the provided undated, unlabeled x-ray by justin templeton md, the x-ray support the complaint.However, without the requested clinical information, operative report, revision report, pre/post radiographs the clinical root cause of the reported aseptic loosening cannot be determined.Based on the information provided, the patient was revised, and the tibial and patella components were removed.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant patient information be provided, this compliant would be re-assessed.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.We consider this investigation closed.

• Brand Name: GNS II NON-POR TIB SZ 7 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11396671
• Report Number: 1020279-2021-01729
• Device Sequence Number: 1167368
• Product Code: JWH
• UDI-Device Identifier: 03596010206374
• UDI-Public: 03596010206374
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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 Model Number: 71420190
• Device Catalogue Number: 71420190
• Device Lot Number: 19FM12705
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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; Required Intervention