MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	200-72-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 00-t193-119-90 - oscillator blade m-class 19/13x 1.19x90mm 547475.200-04-22 - cement type finned tivial tray 2f/2t 3917071.230-03-02 - cr cement type ak femoral components r-2 3931731.A10007 - gps disposable kit 1016015004.Tn190-119-05 - oscillating blade m-class 19x1.19x105 644015.Correction/removal number: z-0019-2022.
Event or Problem Description
As reported, this patient had an initial right tka on (b)(6) 2015.The patient complained of knee swelling and pain and the surgeon diagnosed the wear of the tibial insert.The patient was revised on (b)(6) 2022.Breakage and wear was observed in the retrieved tibial insert, as well as metallosis.The surgeon removed parts and pieces of polyethylene particles and proliferative tissues were resected by the surgeon appropriately.
Additional Manufacturer Narrative
H3: the revision reported was likely due to progressive prosthesis wear over 7 years of implantation secondary to mechanical overload on the posterior medial edge of the tibial insert leading to full thickness polyethylene wear and metallic wear of the tibial tray.Contributions from overall slope of the insert and tibial tray, rotational malalignment and/or soft tissue instability may have allowed for excessive posterior contact leading to wear of the polyethylene insert.However, the contributions of individual factors or a combination of the aforementioned factors cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely due to progressive prosthesis wear over 7 years of implantation secondary to mechanical overload on the posterior medial edge of the tibial insert leading to full thickness polyethylene wear and metallic wear of the tibial tray and/or femoral component.Contributions from overall slope of the insert and tibial tray, rotational malalignment and/or soft tissue instability may have allowed for excessive posterior contact leading to wear and possible fracture of the polyethylene insert.However, the contributions of individual factors or a combination of the aforementioned factors cannot be confirmed as the devices were not available for evaluation.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 2, 9MM, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15969400
• Report Number: 1038671-2022-01594
• Device Sequence Number: 12156039
• Product Code: JWH
• UDI-Device Identifier: 10885862041210
• UDI-Public: 10885862041210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 12/31/2021
• Device Model Number: 200-72-09
• Device Catalogue Number: 200-72-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 03/31/2023; 06/30/2025
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 04/14/2023; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 70 KG