MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-1009
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 92 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, mechanical failure of left total knee replacement requiring revision surgery; injuries to bone and tissue; bilateral left knee pain; swelling, reduced functioning; loss of range of motion; great pain and anguish.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6) 02-010-01-0210 - logic femoral ps cem left sz 1 (b)(6) 02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t (b)(6) 200-02-29 - three peg patella 29mm (b)(6) 203-96-01 - (11-2222) saw blade new stryk (.050) (b)(6) 203-96-03 - (11-2216) saw blade new stryker (.050).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.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loss of range of motion or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.H6: corrected medical device and investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 1 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, INC; 2320 nw 66th ct.; FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20473707
• Report Number: 1038671-2024-04014
• Device Sequence Number: 20644359
• Product Code: JWH
• UDI-Device Identifier: 10885862001689
• UDI-Public: 10885862001689
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 08/08/2019
• Device Catalogue Number: 02-012-35-1009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 08/09/2011
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown