MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3009
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6); 203-96-40 - (11-3973) stryker sys 6 90x25x1.27.(b)(6); 203-96-03 - (11-2216) saw blade new stryker (.050).(b)(6); 200-02-32 - three peg patella 32mm.(b)(6); 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6); 02-010-01-0230 - logic femoral ps cem left sz 3.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 available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 3 months after a left total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, persistent pain, swelling, and loss of range of motion.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: type of investigation.Manufacturer narrative updated: the reason for the revision reported in incident cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.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 and radiographs were not provided.
Additional Manufacturer Narrative
The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.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 and radiographs were not provided.H6: corrected health effect and medical device clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19320912
• Report Number: 1038671-2024-01262
• Device Sequence Number: 20727230
• Product Code: JWH
• UDI-Device Identifier: 10885862001801
• UDI-Public: 10885862001801
• 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: 2020
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 10/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-35-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 11/24/2024; 10/24/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 10/25/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• 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 Sex: Unknown