MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 11MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 4, 11MM, SLOPE +
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products bandeja tibial logic fit 4f/5t (cat# 02-012-45-4050 / serial# (b)(6).Comp.Femoral asimetrico poroso cr nº4 dcha (cat# 232-03-04 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 4 years post initial right tka, the 55 y/o male patient reports spill and synovitis? it does not show pain but lysis is observed in the tibial plateu.Patient was revised to competitor's devices.No further information provided.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of osteolysis.The extent and root cause of the osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3: the revision reported was likely the result of prosthesis wear.A contributing factor to the extent of wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.H6: clinical, problem, and investigation codes updated.The following sections were corrected: h3: prior investigation comments no longer applies.H6: clinical code (osteolysis), problem code (adverse event w/o identified device or use problem), investigation findings (device problem found, packaging materials problem), investigation conclusion (known inherent risk of device) codes no longer apply.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d4, h6.Mdr section codes updated/corrected: b.The revision reported was likely the result of prosthesis wear.A contributing factor to the extent of wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 4, 11MM, SLOPE +
• 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: geoff gannon ; gainesville ; 352554-1928
• MDR Report Key: 18164821
• Report Number: 1038671-2023-02791
• Device Sequence Number: 17972209
• Product Code: JWH
• UDI-Device Identifier: 10885862041128
• UDI-Public: 10885862041128
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 08/07/2025

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: 11/05/2018
• Device Model Number: CR TIBIAL INSERT SZ 4, 11MM, SLOPE +
• Device Catalogue Number: 200-64-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 06/24/2025; 08/07/2025
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 04/18/2024; 06/30/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2010
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 107 KG