MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 15 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR TIB INSERT STD, SZ 3.5, 15 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-010-03-0235 - logic cr femoral cem, left, sz 3.5, sn: (b)(4); 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t, sn: (b)(4); 200-02-32 - three peg patella 32mm sn: (b)(4).Device return anticipated.Recall: z-2112 thru 2133-2021.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 72 yo male patient, initial exactech cr left tka, implant date of (b)(6) 2016, presented with pain, decreased satisfaction, and he stepped down on his knee and felt more pain, and stiffness.A ct showed osteolysis, bone resorption, and a slight fx through the femur at that time.Cultures and infection testing were done on the patient with negative results prior to the revision sx.The poly implant that was in the patient from the original sx was searched within the recall database and did come back as an affected recalled implant.The patient underwent revision surgery, approximately 6 years 6 months post the initial implant procedure, and the surgeon removed the implanted affected poly.The poly appeared to have some cratering/pitting and delamination on the articular surface.The surgeon tested the metal components to make sure that they were well fixed and not loose.The femur and tibia were well fixed.The surgeon trialed with crc trials and decided to re-implant a 15mm crc anterior stabilized poly.The knee was stable, and the patient was stable leaving the operating room.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of the patient conditions reported in the experience report as well as the tibial insert being included in the recall.The insert wear was likely the result of micromotion of the insert within the tray leading to backside wear.The damage and/or wear on the articular surface of the insert appears consistent with being implanted and contact from the edges of the patellar groove on the femoral component.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3.5, 15 MM
• 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 ; 3523771140
• MDR Report Key: 15347483
• Report Number: 1038671-2022-01016
• Device Sequence Number: 20064201
• Product Code: JWH
• UDI-Device Identifier: 10885862159274
• UDI-Public: 10885862159274
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2026

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: 08/16/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 3.5, 15 MM
• Device Catalogue Number: 02-012-47-3515
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/18/2023; 09/18/2023; 06/23/2026
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/18/2023; 09/18/2023; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male