MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	71420170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, there was a revision surgery due to patient experiencing tibial pain and tibial base plate loosening following a primary total knee replacement.The gns ii cmt tib size 6 left and the lgn ps high flex xlpe sz 5-6 13mm were explanted.The procedure was completed with smith and nephew devices.It is unknown if there was a delay.No other complications were reported.
Additional Manufacturer Narrative
It was reported that, there was a revision surgery due to patient experiencing tibial pain and tibial base plate loosening following a primary total knee replacement.The gns ii cmt tib size 6 left and the lgn ps high flex xlpe sz 5-6 13mm were explanted.The procedure was completed with smith and nephew devices.It is unknown if there was a delay.No other complications were reported.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A medical analysis noted that that the requested medical documentation was not available due to lack of consent.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, a thorough assessment cannot be rendered.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time, poor bone quality or patient medical history.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 6 LEFT
• 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: 11240715
• Report Number: 1020279-2021-00694
• Device Sequence Number: 4061973
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 71420170
• Device Catalogue Number: 71420170
• Device Lot Number: 19EM16787
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71453223 LGN PS HIGH FLEX XLPE SZ 5-6 13MM; 71453223 LGN PS HIGH FLEX XLPE SZ 5-6 13MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention