MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	CC TIBIAL INSERT SZ 3, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient returned to hss 20 years after a total knee replacement complaining of pain and instability.The femur and tibia seemed to be well fixed so the insert was removed and a 15mm cck insert was implanted.Patient was last known to be in stable condition following the event.The device is not available for evaluation due to hospital retains all retrievals.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) as reported, patient returned to hss 20 years after a total knee replacement complaining of pain and instability.The femur and tibia seemed to be well fixed so the insert was removed and a 15mm cck insert was implanted.Patient was last known to be in stable condition following the event.The device is not available for evaluation due to hospital retains all retrievals.Upon review of all available information and due to the device not being returned, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.

• Brand Name: CC TIBIAL INSERT SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11783804
• Report Number: 1038671-2021-00217
• Device Sequence Number: 3215204
• Product Code: JWH
• UDI-Device Identifier: 10885862054241
• UDI-Public: 10885862054241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 12/18/2013
• Device Model Number: CC TIBIAL INSERT SZ 3, 9MM
• Device Catalogue Number: 208-23-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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; Disability
• Patient Age: 84 YR