MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-35
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty on the right side.Subsequently, the patient experienced prosthesis wear.As a result, the patient underwent a revision and unknown amount of time post initial implant.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 2 of 2 for this event/patient.
Additional Manufacturer Narrative
D10: 200-01-03 - cemented cr femoral sz 3: sn# (b)(6), 200-23-11 - cr tibial insert sz3, 11mm: sn# (b)(6), 204-04-33 - trapezoid tibial tray sz 3f/3t: sn# (b)(6), 204-32-01 - fluted stem extension 11l x 12 mm: sn# (b)(6), 204-70-00 - tibial stem ext.Screw: sn# (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01102.A definitive root cause was unable to be determined; however, may have been the result of prosthesis wear over 8 years of implantation.Contributing factors to the severity of the wear on the returned tibial insert may have been result of being packaged in a non-conforming vacuum bag for five years, rotational malalignment, and/or instability of the knee combined with high-in vivo loading.However, the contributions of each to the sequence of events cannot be determined as limited clinical information was 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 35MM
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24939525
• Report Number: 1038671-2026-00478
• Device Sequence Number: 17438365
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 09/10/2019
• Device Catalogue Number: 200-02-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female