MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-25-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 76 y/o male patient's knee was revised approximately 15 years 4 months post op.Patient had poly issues with flaking and delamination of the patella ¿ the three lugs had sheared away from the patella.Patient was last known to be in stable condition following the event.Product not returning: it was discarded.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) cem trap tib tray 204-04-54.(b)(6) ps cem.Femoral size 5, right 234-03-05.
Additional Manufacturer Narrative
(h3) the reason for the revision reported is most likely the result of prosthesis wear of the tibial insert and prosthesis wear and fracture of the patellar pegs over the course of 15 years of implantation.However, potential contributions of patient-related considerations to the event could not be assessed from the available information.

• Brand Name: PS TIBIAL INSERTS SZ 5, 11MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19611439
• Report Number: 1038671-2024-02127
• Device Sequence Number: 12338660
• Product Code: JWH
• UDI-Device Identifier: 10885862048479
• UDI-Public: 10885862048479
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 03/01/2011
• Device Catalogue Number: 204-25-11
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2006
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 80 KG