MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 78 year old female patient had an initial right tka on (b)(6) 2020.The patient was revised on (b)(6) 2022 due to poly delamination and pitting.Everything was removed.The patient was not revised to exactech devices.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Product not returning: disposed at hospital.Unable to obtain x-rays.
Additional Manufacturer Narrative
(d10) concomitant device(s): 5059560 (b)(6) - logic cr femoral cem, right, sz 3.5440247 (b)(6) - threaded pin size 2.3 collared.5628452 (b)(6) - lgc tibial fit tray cem sz 3f / 2t.6486308 (b)(6) - holding pin mini sharp point 4 pk.6528582 (b)(6) - three peg patella 35mm.6557688 (b)(6) - 3 trocar, mod.Hex 2pk.S006532 (b)(6) - threaded pin size 2.3 collared.S016073 (b)(6) - threaded pin size 3.0 collarless.(h3) the reason for the revision reported may be due to prosthesis wear as reported or inclusion of the polyethylene in the packaging recall.While minor scratches and pitting are visible in the provided image, the reported delamination could not be confirmed on the image of the explanted tibial insert.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19512144
• Report Number: 1038671-2024-01893
• Device Sequence Number: 12622837
• Product Code: JWH
• UDI-Device Identifier: 10885862230409
• UDI-Public: 10885862230409
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 02-012-51-3009
• 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: 03/18/2024
• Initial Report FDA Received Date: 06/11/2024
• Date Device Manufactured: 09/04/2018
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 52 KG