MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420166
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was conducted because the patient presented pain and loosening of the base plate.The surgeon says the devices were not defective.The current status of the 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, the patient underwent a revision surgery due to pain and loosening of the baseplate.Per email communication, the requested surgical reports and x-rays are not available.However, it was stated that the surgeon said the devices were not defective.Therefore, patient impact beyond the revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, patient reaction and 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 CMT TIB SIZE 4 LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10731242
• Report Number: 1020279-2020-05726
• Device Sequence Number: 4123751
• Product Code: JWH
• UDI-Device Identifier: 03596010206268
• UDI-Public: 03596010206268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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 Expiration Date: 09/01/2025
• Device Model Number: 71420166
• Device Catalogue Number: 71420166
• Device Lot Number: 15JT58469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 07/13/2021
• 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: 71453211 LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention