MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (b)(4).Case no.(b)(4).Refer to (b)(4) for rk current.It was reported that approximately 44 months after a right total knee replacement procedure, the patient has experienced prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Concomitants: (b)(6), 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t, (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 02-010-03-0320 - logic cr femoral cem, right, sz 2.The product associated with the reported event is within the scope of recall z-0021-2022.However, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 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 66th ct; gainesville 32606 6841
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20001380
• Report Number: 1038671-2024-02891
• Device Sequence Number: 11980922
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 11/08/2019
• Device Catalogue Number: 02-012-49-2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 08/20/2024
• Date Device Manufactured: 11/09/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown