MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Model Number	CC TIBIAL INSERT SZ 3, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: concomitants: 6663920 201-78-15 - holding pin mini sharp point 4 pk.5545186 201-78-81 - 3 trocar, mod.Hex 2pk.5776328 201-78-81 - 3 trocar, mod.Hex 2pk.5604250 201-78-87 - 4 trocar, mod.Hex.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that 58 yo male patient, initial right knee implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2023, approximately 2 years 1 month post the initial procedure due to poly wear.The insert was replaced.There were no surgical delays reported.The patient was last known to be in stable condition following the event.The device is not available for return as it was disposed of by the hospital.
Event or Problem Description
Patient had the intial tka implant procedure on (b)(6) 2013, was revised on (b)(6) 2021, and underwent this second revision procedure on (b)(6) 2023.The first revision procedure was reported under 1038671-2021-00108.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of prosthesis wear, as stated in the experience report.However, the reason for the wear could not be determined as the device was not returned for evaluation and images were not provided.

• Brand Name: CC TIBIAL INSERT SZ 3, 13MM
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16591531
• Report Number: 1038671-2023-00487
• Device Sequence Number: 3021281
• Product Code: JWH
• 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 Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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 Expiration Date: 05/08/2022
• Device Model Number: CC TIBIAL INSERT SZ 3, 13MM
• Device Catalogue Number: 208-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 09/14/2026
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/15/2023; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male