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

Catalog Number	02-012-51-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitatnts: a10012 - gps implant kit v2 (b)(6).02-010-04-0340 - logic cr femoral por, right, sz 4 (b)(6).521-78-32 - threaded pin size 3.0 collarless (b)(6).201-78-81 - 3 trocar, mod.Hex 2pk (b)(6).201-78-15 - holding pin mini sharp point 4 pk (b)(6).02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t (b)(6).521-78-23 - threaded pin size 2.3 collared (b)(6).521-78-23 - threaded pin size 2.3 collared (b)(6).
Event or Problem Description
It was reported that a 63 yo male patient who had an initial right knee implanted in (b)(6) 2021, and was revised in (b)(6) 2022, underwent a second revision procedure in (b)(6) 2024, approximately 2 years post the (b)(6) 2022 procedure.Everything was revised due to wear on patella and tibial insert and was replaced with a competitor¿s devices.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for analysis.They were discarded at the hospital.Device images were provided.No further information.First revision reported under mdr# 1038671-2022-01234.
Additional Manufacturer Narrative
Report number: 1038671-2024-04239 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3: device not returned.The reason for the revision may be the result of wear of the patella and third body wear on the tibial insert.Contributions of patient-related issues or implant alignment to the wear on the patella cannot be confirmed from the information provided and the devices were not available for evaluation.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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20612627
• Report Number: 1038671-2024-04238
• Device Sequence Number: 15285669
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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 Catalogue Number: 02-012-51-4011
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male