MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 3, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in person site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.This patient (b)(6) was implanted with a 208-23-13-inserto tibial cc 3,13mm, serial number: (b)(6) on (b)(6) 2019.The insert was manufactured on 5-jul-2016 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 5-jul-2016 and was 3 years shelf age at the time of implant.Approximately four years post implantation, the patient underwent revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3 the revision reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components, which led to prosthesis wear.However, this cannot be confirmed as the devices were not available for evaluation and images of the explanted device/radiographs were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b3, b5 (report #1 of 2 for this event), d6b, d10, e4 (remove erroneous entry from initial report), g2 (spain), h6: clinical code, investigation findings, investigation conclusion and h10.D10: 200-04-34 - tib cemented fin tray 3f/4t 274452.02-11 232-02-03 - porous asymmetric femoral comp.Cr nº3 izq 274452 2013-02-11 02-012-45-3040 - logic fit 3f/4t tibial tray 274452.200-02-32 - three-lug ball joint 32mm 274452.204-34-04 - ext.14x40mm stem 274452 2019-05-15 204-34-08 - ext.Stem 14x80mm 274452.208-01-03 - femur cc nº3 274452 2019-05-15 208-09-05 - 5 degree dc rod femoral adapter 274452 208-23-13 - tibial insert cc 3.13mm 274452.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2026-00442.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CC TIBIAL INSERT SZ 3, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16971078
• Report Number: 1038671-2023-01070
• Device Sequence Number: 12110695
• Product Code: JWH
• UDI-Device Identifier: 10885862054265
• UDI-Public: 10885862054265
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 07/04/2021
• Device Model Number: CC TIBIAL INSERT SZ 3, 13MM
• Device Catalogue Number: 208-23-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 03/26/2026
• Initial Report FDA Received Date: 05/21/2023
• Supplement Report FDA Received Date: 07/26/2023; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown