MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-24-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 56 y/o male patient's right knee was revised.In (b)(6) 2014, a cr was implanted in the right knee.In 2018 the patient reported discomfort.In 2019, mobilization, asymmetry and involvement of the external tibial plateau were observed in the x-rays.In 2019, the replacement was carried out, observing synovectomy, cyst in the internal condyle, tibial plateaus with cysts and total destruction of the internal condyle.Patient was revised with competitors device.Images & x-rays not provided.
Additional Manufacturer Narrative
(d10) concomitant device(s): 3677278 232-03-04 - optetrak asy, cr porous femoral, sz 4, right.4241688 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t.4358995 02-010-01-0240 - logic femoral ps cem left sz 4.4498584 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm.4564277 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.
Additional Manufacturer Narrative
Section h10: (a2) 56 years (h3) the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear and 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 corrected information.The following sections were corrected: h6: health effect: clinical code, investigation findings, investigation conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CR TIBIAL INSERT SZ4, 11MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18101203
• Report Number: 1038671-2023-02727
• Device Sequence Number: 12151543
• Product Code: JWH
• UDI-Device Identifier: 10885862040305
• UDI-Public: 10885862040305
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2025

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: 04/12/2018
• Device Catalogue Number: 200-24-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 06/10/2025; 11/12/2025
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/20/2023; 06/30/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 112 KG