MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 3009016032 a10012 - gps implant kit v2 4376257 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t 4394472 02-010-01-0235 - logic femoral ps cem left sz 3.5 4495762 204-34-04 - fluted stem extension 40l x 14 mm 4552552 200-02-35 - three peg patella 35mm 4553238 204-70-00 - tibial stem ext.Screw 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.
Event or Problem Description
Legal case ¿ (b)(4).It was reported that approximately 96 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, pain, stiffness, discomfort and weakness which in turn negatively affected patient mobility and quality of life.Patient currently scheduled for a revision surgery in (b)(6) 2024.No further issues or complications were reported.No additional information is available.***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510(k): k110547.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 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; FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20152325
• Report Number: 1038671-2024-03329
• Device Sequence Number: 8397104
• Product Code: JWH
• UDI-Device Identifier: 10885862173607
• UDI-Public: 10885862173607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2023
• Device Catalogue Number: 02-012-44-3511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 11/30/2015
• 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
• Patient Sex: Unknown