MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Joint effusion (4849)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 53 y/o female patient had a right knee replacement on (b)(6) 2015.Approximately 7 years after the initial procedure the patient had a right knee revision on (b)(6) 2022.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 return.There are no photos or other images of the device provided.No additional information is available.Revision op report on 8 dec 2022 diagnosis: right instability of knee prosthesis intraoperative findings revealed a moderate to large amount of normal-appearing joint fluid.All components appear to be well fixed and in good position.There was medial tibial osteolysis affecting about 20% of the component.There was a large amount of posterior condylar osteolysis on the lateral side of the femur.The polyethylene liner had severe wear on the medial side with pitting and delamination.There were no complications.The patient was then taken to the recovery room in satisfactory condition.
Additional Manufacturer Narrative
D10: concomitants: 02-010-01-0225 - logic femoral ps cem left sz 2.5, 4045506.02-010-01-0325 - logic femoral ps cem right sz 2.5, 4139570.02-012-35-2509 - logic tibia ps mod insrt sz 2.5 9mm, 3683005.02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t, 4076236.02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t, 4154751.200-02-32 - three peg patella 32mm, 4167503.200-02-35 - three peg patella 35mm, 4186839.204-34-02 - fluted stem extension 25l x 14 mm, 4205727.204-34-02 - fluted stem extension 25l x 14 mm, 4206933.204-70-00 - tibial stem ext.Screw, 4139984.204-70-00 - tibial stem ext.Screw 4144631 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 instability 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 and radiographs were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 17349409
• Report Number: 1038671-2023-01704
• Device Sequence Number: 17416066
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 03/20/2021
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 03/26/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female