MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately eight years post initial left tka, this (b)(6) male patient underwent revision of the total tkr optetrak due to poly wear and debris in the knee were indicated.There was no breakage of a device.There was no surgical delays reported.Patient was last known to be in stable condition following the event.X-rays were not able to be obtained by sales rep.Device images received.The device will be return.
Additional Manufacturer Narrative
Concomitant products: optetrak 3 peg patella (cat# 200-02-32 / serial# (b)(4)) optetrak tibial tray (cat# 204-04-44 / serial# (b)(4)) optetrak asymmetric femoral posteriar stabilizer (cat# 234-02-04 / serial# (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3, h6, h7 and h9 have been updated accordingly.(h3 the revision reported was likely the result of detachment of the tibial tray¿s medial posterior screw hole cap at the time of implantation, which prevented the tibial insert from fully seating, leading to micromotion and extensive backside wear of the polyethylene over time.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: PS TIBIAL INSERTS SZ 4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14269728
• Report Number: 1038671-2022-00503
• Device Sequence Number: 5842591
• Product Code: JWH
• UDI-Device Identifier: 10885862048394
• UDI-Public: 10885862048394
• 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: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 07/16/2020
• Device Model Number: PS TIBIAL INSERTS SZ 4, 11MM
• Device Catalogue Number: 204-24-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male