MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-51-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post op the initial right tka, this female patient was revised due to a swollen knee and pain caused due to poly wear from the bad batch of poly.Insert and patella changed.Patient revised to exactech device.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-010-04-0340 - logic cr femoral por, right, sz 4 4719880, 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t 6029557, 200-02-41 - three peg patella 41mm 4481559,.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was most likely the result of prosthesis wear initiated by unintended contact between incongruent surfaces of the tibial insert and femoral component.However, contributions from instability of the knee joint, component alignment, and/or patient-conditions to the sequence of events cannot be determined from the reported clinical information.Having been packaged in a non-conforming vacuum bag for more than five years may also have been contributing factor to the extent of wear noted on the tibial insert.The following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, g2 (correct initial report - australia), h6: clinical code, investigation findings, investigation conclusions.The revision reported was most likely the result of prosthesis wear initiated by unintended contact between incongruent surfaces of the tibial insert and femoral component.However, contributions from instability of the knee joint, component alignment, and/or patient-conditions to the sequence of events cannot be determined from the reported clinical information.Having been packaged in a non-conforming vacuum bag for more than five years may also have been contributing factor to the extent of wear noted on the tibial insert.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15537129
• Report Number: 1038671-2022-01234
• Device Sequence Number: 5996904
• Product Code: JWH
• UDI-Device Identifier: 10885862230492
• UDI-Public: 10885862230492
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 12/31/2025

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: 02/14/2022
• Device Model Number: 02-012-51-4011
• Device Catalogue Number: 02-012-51-4011
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 12/15/2025
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 02/06/2023; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2014
• 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
• 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 Sex: Female