MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.4 years post initial left tka, the 72 y/o female patient returned to surgeon's office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap versus full revision.The patient underwent a revision tka with a poly swap and patella swap.Patent was revised to truliant crc tibial insert sz 2, 15mm and optetrak 3 peg patella cemented 32mm.Patient had poly debris.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to the implant was sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitant devices: (b)(6) 02-012-49-2011 - logic cr tib insert slope++, sz 2, 11mm, (b)(6) 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t, (b)(6) 02-010-03-0220 - logic cr femoral cem, left sz 2.

• Brand Name: THREE PEG PATELLA 29MM
• 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
• MDR Report Key: 21420430
• Report Number: 1038671-2025-01112
• Device Sequence Number: 8188950
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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 Expiration Date: 01/02/2024
• Device Catalogue Number: 200-02-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 01/04/2019
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 96 KG