MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 7 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420172
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr surgery had been performed on (b)(6) 2020, the gns ii cmt tib size 7 left became loose.This adverse event was solved by a revision surgery on (b)(6) 2021.Current health status of 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, this case reports the patient had a left tkr and had a revision 9 months later due to the gns ii cmt tib becoming loose.However, it is noted within the attachments that no medical records are available.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.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 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, lack of ingrowth 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 CMT TIB SIZE 7 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12422520
• Report Number: 1020279-2021-06725
• Device Sequence Number: 3662059
• Product Code: JWH
• UDI-Device Identifier: 03596010206299
• UDI-Public: 03596010206299
• 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: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420172
• Device Catalogue Number: 71420172
• Device Lot Number: 19LB00059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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