MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-23-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 200-04-33 - bandeja tib cementada aleta 3f/3t.(b)(6), 232-02-03 - comp.Femoral asimetrico poroso cr nº3 izq.
Event or Problem Description
As reported, on (b)(6) 2023 this patient was implanted with a 200-23-09 cr tibial insert sz3, 9mm, serial number (b)(6) on (b)(6) 2011.Patient was revised on (b)(6) 2022 due to polyethylene wear.No additional details are available at this time the insert was manufactured on 6/9/2010 and was packaged in a vacuum bag with no evoh.No other information was provided at this time.
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 may have led to prosthesis wear.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.However, this failure cannot be confirmed as it was not reported, and the device was not available for evaluation and images of the explanted device /radiographs 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 additional and/or corrected information.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 may have led to prosthesis wear.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.However, this failure cannot be confirmed as it was not reported, and the device was not available for evaluation and images of the explanted device /radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, h6, h11.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear.Potential root causes of uneven pressure distribution from the alleged joint instability and/or potential malalignment of the femoral and/or tibial component could not be confirmed from the provided information.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported approximately 131 months after a total knee arthroplasty (unknown side) a patient underwent a revision.Patient presented with pain, mild instability and mild tibial osteolysis approximately 4 years post initial surgery.Approximately 8 years post the initial surgery, it was observed the patient had experienced tibial osteolysis, while the femur remained in good health.It was reported approximately 1 year prior to the revision surgery, the patient showed evidence of osteolysis in both the tibia and femur.The patient was revised to a competitor's construct.No post operative reports were provided.A photo of the explanted insert was provided.No surgical or medical interventions were reported.Patient's outcome post operatively was reported as unknown.

• Brand Name: CR TIBIAL INSERT SZ3, 9MM
• 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: 18347182
• Report Number: 1038671-2023-03012
• Device Sequence Number: 20234165
• Product Code: JWH
• UDI-Device Identifier: 10885862040244
• UDI-Public: 10885862040244
• 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: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/26/2025

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: 06/08/2018
• Device Catalogue Number: 200-23-09
• 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: 03/25/2024; 11/04/2024; 05/12/2025; 08/04/2025
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/29/2024; 12/02/2024; 05/12/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2010
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 77 KG