MAUDE Adverse Event Report: EXACTECH, INC. ADVANCED PATELLA 32MM 3 PEG IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-07-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: 4857086 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.
Event or Problem Description
As reported, approximately 5 years and 9 months post the initial left total knee arthroplasty, the patient complained of pain and was revised due to a loose femur and bad poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Additional information received via legal notification noted that the patient underwent the revision procedure to address wear, loosening, pain, stiffness, swelling, discomfort, weakness, and instability.
Additional Manufacturer Narrative
The reason for the revision reported was likely the result of pain, which was caused by prosthesis wear, instability, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The reason for the reported loosening cannot be confirmed as the devices were not returned for evaluation.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-bone interface and/or cement-implant interface; however, this cannot be confirmed.Prosthesis wear of the tibial insert could not be confirmed from the images provided.Possible causes for polyethylene wear for the patella include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability or any combination of these possibilities.D10 concomitant devices: 02-020-11-0330 - truliant ps cem fem ps cem right sz 3 (b)(6).02-022-35-3009 - truliant tib imp ps insert sz 3 9mm (b)(6).02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t (b)(6).200-07-32 - advanced patella 32mm 3 peg implant (b)(6).02-020-11-0230 - truliant ps cem fem ps cem left sz 3 (b)(6).02-022-35-3009 - truliant tib imp ps insert sz 3 9mm (b)(6).02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t (b)(6).H6: corrected health effect and investigation clinical codes.

• Brand Name: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• 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: 22087853
• Report Number: 1038671-2025-02147
• Device Sequence Number: 17876418
• Product Code: JWH
• UDI-Device Identifier: 10885862314284
• UDI-Public: 10885862314284
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 04/30/2023
• Device Catalogue Number: 200-07-32
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 05/01/2018
• 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 Age: 74 YR
• Patient Sex: Female