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

Catalog Number	02-012-35-3511
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/25/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: (b)(6) 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 02-010-01-0335 - logic femoral ps cem right sz 3.5.
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on(b)(6) 2014, with no reported revision.No other patient information / medical history reported.No radiographic images of the device are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H6: corrected health effect - clinical code, health effect - impact code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and range of motion and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC TIBIA PS MOD INSRT 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19103880
• Report Number: 1038671-2024-00835
• Device Sequence Number: 7607208
• Product Code: JWH
• UDI-Device Identifier: 10885862001856
• UDI-Public: 10885862001856
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• 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): 10/10/2024

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: 03/18/2022
• Device Catalogue Number: 02-012-35-3511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• 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 Sex: Unknown