MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 38MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-38
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.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 prosthesis wear, osteolysis, and femoral loosening could not be determined as the devices were not returned for evaluation, and radiographs were not provided.D10: (b)(6) - 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.(b)(6) - 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) - 201-78-81 - 3 trocar, mod.Hex 2pk.(b)(6) - 521-78-23 - threaded pin size 2.3 collared.(b)(6) - 521-78-23 - threaded pin size 2.3 collared.(b)(6) - 521-78-32 - threaded pin size 3.0 collarless.(b)(6) - a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately five years post initial right total knee arthroplasty, the patient was revised due to polyethelene wear and femoral loosening, as a result of osteolysis.The patient was revised to a size 4 femoral component and a size 4 tibial insert.There was breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to the devices were disposed at hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h11.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that there appears to be evidence of third body wear on the articular surface of the tibial insert.Third body wear occurs when a third body, such as a fragment of bone or bone cement, gets trapped between the articulating surfaces of the tibial insert and femoral component.As the patient moves, the third body creates scratches, and sometimes pitting, on the surface of the tibial insert.The patella appears to have some scratching, and damage along the edge of the patella.Both damage patterns appear consistent with tool damage sustained during device removal.The retained bone adhered to the porous surface of the femoral component, which appears consistent with fixation between the femoral component and the patient¿s bone.The absence of bony ingrowth may be indicative of femoral loosening.However, this cannot be confirmed from the available information.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from tibial insert prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone which led to aseptic (non-infected) femoral loosening.The patella wear could not be confirmed from the provided information.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 prosthesis wear, osteolysis, and femoral loosening could not be determined as the devices were not returned for evaluation, and 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.

• Brand Name: THREE PEG PATELLA 38MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22126455
• Report Number: 1038671-2025-02219
• Device Sequence Number: 20703951
• Product Code: JWH
• UDI-Device Identifier: 10885862039613
• UDI-Public: 10885862039613
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 06/28/2023
• Device Catalogue Number: 200-02-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male