MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-1515
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6), 02-012-45-1515, lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6), 200-02-32, three peg patella 32mm (b)(6), 02-010-01-0215, logic femoral ps cem le.Ft sz 1.5.(b)(6), 204-70-00, tibial stem ext.Screw.(b)(6), 204-32-02, stem extension 25 lx12 mm.
Event or Problem Description
As reported, approximately 2 years post op left knee replacement, this 67 y/o female patient was revised due to poly wear.Everything was removed and used a revision knee from other company.Patient was last known to be in stable condition following the event.No x-rays provided, unable to obtain.No product return, disposed at the hospital.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of prosthesis wear that may have been secondary to instability.A contributing factor to the extent of wear on the insert may be the result of having been packaged in an out-of-specification bag for more than 5 years.However, this cannot be confirmed as the device was not available for evaluation and limited clinical information was available.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear that may have been secondary to instability.A contributing factor to the extent of wear on the insert may be the result of having been packaged in an out-of-specification bag for more than 5 years.However, this cannot be confirmed as the device was not available for evaluation and limited clinical information was available if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 15MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17430826
• Report Number: 1038671-2023-01818
• Device Sequence Number: 15260238
• Product Code: JWH
• UDI-Device Identifier: 10885862173461
• UDI-Public: 10885862173461
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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: 02/10/2023
• Device Catalogue Number: 02-012-44-1515
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 02/04/2025
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 11/01/2023; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2015
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female