MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/MET/POL

Model Number	71420166
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after 13 years of the primary tka surgery, the sz4 tibia became loose.A revision surgery took place to replace the genesis ii cmt tib size 4 left.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 that 13 years post-implantation, the cemented tibia was revised due to loosening.Per email communication, the requested x-rays and surgical reports are not available.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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 CMT TIB SIZE 4 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POL/MET/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10822931
• Report Number: 1020279-2020-06363
• Device Sequence Number: 3204494
• Product Code: JWH
• UDI-Device Identifier: 03596010206268
• UDI-Public: 03596010206268
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 71420166
• Device Catalogue Number: 71420166
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 08/17/2021
• 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: Required Intervention