MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-22-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on 28-nov-2023 this patient was implanted with a 208-22-11cc tibial insert sz 2, 11mm, serial number (b)(6) on (b)(6) 2015.Patient revised on (b)(6) 2023 due to polyethylene wear with osteolysis.No additional details are available at this time.The insert was manufactured on 2/13/2015.And was packaged in a vacuum bag with no evoh.No other information was provided at this time.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 02-012-45-2020 - bandeja tibial logic fit 2f/2t.(b)(6), 204-34-08 - vastago ext.14x80mm.(b)(6), 204-36-08 - vastago ext.16x80mm.(b)(6), 208-01-02 - femur cc nº2.(b)(6), 208-09-07 - adaptador femoral vastago cc 7 grados.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of polyethylene 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.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.
Additional Manufacturer Narrative
The following sections have corrected information: h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: health effect - clinical code, type of investigation, investigation findings, investigation conclusion the revision reported was likely caused by osteolysis, prosthesis wear, or the reported femoral loosening.Possible causes for polyethylene wear include the alleged femoral loosening, rotation or malalignment of the femoral component such that the femoral condyle or cam radius contacts the tibial spine, inclusion of the polyethylene in the packaging recall or any combination of these possibilities.Failure of the cement used to secure the femoral component to the femoral bone, may have led to loosening at the cement-implant and/or cement-bone interface, however, this cannot be confirmed as images of the explanted device and pre-revision radiographs were not provided.

• Brand Name: CC TIBIAL INSERT SZ 2, 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: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18347108
• Report Number: 1038671-2023-03011
• Device Sequence Number: 17692730
• Product Code: JWH
• UDI-Device Identifier: 10885862054173
• UDI-Public: 10885862054173
• 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: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2025

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: 02/11/2020
• Device Catalogue Number: 208-22-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/27/2024; 11/04/2024; 07/29/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/29/2024; 12/02/2024; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 83 KG