MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2015
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 168 months after a left total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, pain and discomfort, swelling, gait impairment, poor balance, and component part loosening.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices are unknown the device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, type of investigation.The reason the reported event cannot be confirmed from the information provided but may be related to inclusion of the polyethylene in the packaging recall.Additionally, the devices were implanted for over ten years prior to the reported failures.Potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no product information, images, radiographs, or relevant clinical information was provided.
Additional Manufacturer Narrative
Corrected fields: a2-3, b1-3, b5, d6b, d10, g4, h6 health effect impact code and medical device problem code.D10: ((b)(6)) 200-02-35 - three peg patella 35mm.((b)(6)) 02-012-41-2020 - logic tibia traptray cem sz 2f/2t.((b)(6)) 02-010-01-0220 - logic femoral ps cem left sz 2.
Event or Problem Description
It was reported via legal documentation that approximately 168 months ago the patient underwent a left total knee replacement procedure and remains unrevised at time of reporting.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03676.This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear, loosening and/or 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.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.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 2 15MM
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19237120
• Report Number: 1038671-2024-01031
• Device Sequence Number: 12788871
• Product Code: JWH
• UDI-Device Identifier: 10885862001757
• UDI-Public: 10885862001757
• 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: 2009
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 12/21/2013
• Device Catalogue Number: 02-012-35-2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 09/19/2024; Not provided; Not provided
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/23/2024; 12/04/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2008
• 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: CONCOMITANT DEVICES ARE UNKNOWN.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male