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

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a 50 yo female patient, initial left knee implanted on (b)(6) 2015, underwent a revision total knee replacement procedure on (b)(6) 2022, approximately 6 years 10 months post the initial procedure.The patient was seen in the office with a failed left total knee replacement refractory to conservative management.Imaging was consistent with failed left knee arthroplasty.The patient was indicated for surgery.Informed consent was obtained by the patient who understood the risks and benefits of the procedure and wished to proceed.Implants were removed.The femoral component was grossly loose and was removed by hand.Attention turned to the tibia.The tibia was removed with minimal bone loss.The patient was re-implanted with a competitor¿s devices.A condylar constrained total knee prosthesis with stems on the femoral and tibial components were inserted.The patient was transferred to the recovery room in stable condition.The pre-op and post-op diagnosis indicated mechanical loosening of the internal left knee prosthetic joint.Primary device reported is the poly liner.Femur device information is unknown.No device returns anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening 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.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 IMPLANT PSC INSERT, 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16801773
• Report Number: 1038671-2023-00809
• Device Sequence Number: 3062073
• Product Code: JWH
• UDI-Device Identifier: 10885862173553
• UDI-Public: 10885862173553
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2023
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• Device Catalogue Number: 02-012-44-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 05/14/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female