MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) the revision reported was likely due to progressive prosthesis wear over 5 years of implantation secondary to mechanical overload on the posterior edges of the tibial insert leading to full thickness polyethylene wear and reported metal-on-metal wear.Contributions from overall slope of the insert and tibial tray and/or soft tissue instability may have allowed for excessive posterior contact leading to wear of the polyethylene insert.However, the contributions of individual factors or a combination of the aforementioned factors cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Event or Problem Description
As reported, after about 5 years later from a primary surgery, the 81 y/o female patient who had total knee arthroplasty using cr slope ++ tibial insert complained knee swelling and pain, the surgeon diagnosed the wear of the tibial insert, then revision surgery for the replacement of the tibial insert was performed.Breakage and wear was observed in the retrieved tibial insert.Also, he found out metallosis.He decided that no problem of locking mechanism of the tibial tray was found, and removing all proliferative tissues, the insert only was replaced to new one.Polyethylene particles and proliferative (growth) tissues on the surgical field were resected by the surgeon appropriately.There was no surgical delay/prolongation.Photos and x-rays received.The device is not available for evaluation due to retrieved insert would be used for clarification to a patient.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16696044
• Report Number: 1038671-2023-00597
• Device Sequence Number: 20251377
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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: 03/13/2026
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM
• Device Catalogue Number: 02-012-49-2009
• 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: 03/16/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2018
• 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: GPS DISPOSABLE KIT; INFORMATION FEE; LOGIC CR CEMENT FEMORAL RIGHT, 2; LOGIC CR SLOPE WITH TIBIAL INSERTS++, 2 - 9MM; LOGIC FIT CEMENT TIVIAL TRAY 2F/2T; LOGIC TKA SET; OSCILLATING BLADE M-CLASS 19X1.19X105; OSCILLATOR BLADE M-CLASS 19/13X 1.19X90MM; OSCILLATOR JAV STREAMING OSCILLATOR; REAMER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 42 KG