MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a patient has a planned knee arthroplasty revision scheduled for (b)(6) 2024 by (b)(6).Records search located an initial surgery for (b)(6) by(b)(6) on (b)(6) 2014.Components implanted are listed below and attached.At the time of legal notification: there is no other patient demographic or medical history available, there is no information on the surgical procedure or patient outcome, there is no device returned, there are no photos, radiographs or other images of the device provided.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H7 - recall number z-0021-2022 h3 - pending investigation d10 concomitants: 02-010-01-0330 - logic femoral ps cem right sz 3, serial number (b)(6), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, serial number (b)(6), 200-02-38 - three peg patella 38mm, 2923903.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d6b, h6 (type of investigation, investigation findings, investigation conclusions) the following sections were corrected: h6 (health effect - clinical code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 13MM
• 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; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 352 275-3978
• MDR Report Key: 19125693
• Report Number: 1038671-2024-00893
• Device Sequence Number: 15543653
• Product Code: JWH
• UDI-Device Identifier: 10885862001825
• UDI-Public: 10885862001825
• 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: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2018
• Device Catalogue Number: 02-012-35-3013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown