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 Code	Pain (1994)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years and 2 months post initial left total knee arthroplasty (tka), a revision was performed due to complaint of pain.For the revision, intersep and an interspace were used.There was no reported breakage of the device and no surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 02-029-99-1001 - fluted headless pin 3.0" square head, pk2 (b)(6); 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t (b)(6); 02-020-11-0250 - truliant ps cem fem ps cem left sz 5 (b)(6); 02-022-35-5013 - truliant tib imp ps insert sz 5 13mm (b)(6); 204-70-00 - tibial stem ext.Screw (b)(6); 02-012-60-1440 - tru stem ext 14mm x 40mm (b)(6).
Additional Manufacturer Narrative
The revision reported was likely the result of the reported pain and the patellar prosthesis wear.The reason for the clinical symptom of pain cannot be conclusively determined.Potential causes of the observed polyethylene wear include third body wear, patient-related causes or any combination of these possibilities.However, these potential causes cannot be confirmed.H6: corrected component, 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: 20497017
• Report Number: 1038671-2024-04053
• Device Sequence Number: 19712845
• 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: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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?: Yes
• Operator of Device: Health Professional
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 07/26/2025
• Date Device Manufactured: 05/26/2022
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male