MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: exactech knee replacement study; subject: (b)(6).As reported, this 79 year old, male patient had a left tka on (b)(6) 2014.The patient presented with effusion in 2022 and polyethylene wear without evidence of osteolysis - effusion on (b)(6) 2024.Inpatient hospitalization for revision - right total knee replacement (poly exchange plus patella resurfacing).Action taken: revision.Revision is performed on (b)(6) 2024.The outcome of this event is considered resolved on (b)(6) 2024.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities and no device return anticipated.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-010-01-0240 - logic femoral ps cem left sz 4.02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.200-02-38 - three peg patella 38mm.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the revision reported was likely the result of prosthesis wear of the tibial insert over 9 years of implantation.The cause and extent of the wear cannot be determined because the revised components were not returned for evaluation and no images or radiographs were provided.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18788502
• Report Number: 1038671-2024-00326
• Device Sequence Number: 7757119
• Product Code: JWH
• UDI-Device Identifier: 10885862001900
• UDI-Public: 10885862001900
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-35-4013
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 97 KG