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	10/23/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a total knee arthroplasty on (b)(6) 2014.The patient has not been surgically revised.There is no other patient or medical information provided.There are no images of the device provided.No additional information is available.The provided/ searchable information does not clarify the leg in which the device was actually implanted.
Additional Manufacturer Narrative
H10.D10.Concomitants: 3709498 02-010-01-0230 - logic femoral ps cem left sz 3 2031811 02-012-41-3030 - logic tibia traptray cem sz 3f/3t aa7493 1200-a - cemex rx 40g low viscosity 3559099 200-02-35 - three peg patella 35mm 3620962 201-78-81 - 3" trocar, mod.Hex 2pk 3730636 201-78-88 - 4" drill bit, mod.Hex 2-pk 3688501 204-34-02 - fluted stem extension 25l x 14 mm 3744151 204-70-00 - tibial stem ext.Screw 5385043 02-022-44-3011 - truliant tib imp psc insert sz 3, 11mm these devices are used for treatments, not diagnosis.There is no other information available.Pending investigation.
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/or due to inclusion of the polyethylene in the packaging recall.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.

• 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 19029839
• Report Number: 1038671-2024-00718
• Device Sequence Number: 20874875
• Product Code: JWH
• UDI-Device Identifier: 10885862001825
• UDI-Public: 10885862001825
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 09/02/2022
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 09/03/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Unknown