MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 {} RIGHT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTD,POLYMRMETALPOLYMR

Model Number	71420184
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on the (b)(6) 2019, the patient experienced pain.An imaging done with contrast found that the gns ii cmt tib size 4 {} right was loose.A revision surgery was performed on the (b)(6) 2022 to treat this adverse event.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a revision was performed approximately 2.5 years post implantation due to pain and suspected loosened tibial baseplate per contrast imaging.It was communicated that the requested clinical documentation is not available; however, reportedly, the surgeon does not fault the components.Reportedly, the revision went perfect, and the surgeon was satisfied with the outcome.Without the requested clinical documentation, the root cause could not be further assessed.The patient impact beyond the reported pain with suspected tibial component loosening on imaging and revision could not be determined.No further medical assessment could be rendered at this time.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveals in the possible adverse effects section that loosening, bending, cracking, or fracture of implant components can occur as a result of trauma, strenuous activity, improper alignment, or duration of service.A historical review concluded that there are no prior actions related to this product and event.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.The contribution of the device to the reported event could not be corroborated.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.Internal complaint reference number: (b)(4).

• Brand Name: GNS II CMT TIB SIZE 4 {} RIGHT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTD,POLYMRMETALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14385787
• Report Number: 1020279-2022-02360
• Device Sequence Number: 6527312
• Product Code: JWH
• UDI-Device Identifier: 03596010206343
• UDI-Public: 03596010206343
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 71420184
• Device Catalogue Number: 71420184
• Device Lot Number: 19BT16935
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GII OXIN P/S FEM RIGHT SZ 6, 19AM21070; GNS II RESURF PAT 35MM, 18LB00385; LGN PS HIGH FLEX XLPE SZ 3-4 13MM, 19CM04206
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown