MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-44-1011
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal notification, the patient had bilateral tkas on (b)(6) 2017.The patient was noted to have some discomfort in the right knee.The patient was screened pre-operatively for infection.Based on clinical history, exam, and laboratory data, there was no concern for infection.Given the patient's persistent pain and recall of her implant, discussion was held regarding revision arthroplasty.The patient's right knee was revised on (b)(6) 2023.An extensive synovectomy of the medial gutter, lateral gutter, suprapatellar pouch, and fat pad was performed.The patella was subluxated laterally.The polyethylene insert was removed and there was significant damage.There were free pieces of sheared off polyethylene floating.Additionally the post had significant damage at its anterior aspect.The femoral component was found to be well fixed on the lateral side.On the medial side there was some osteolysis.Using a combination of a revision sawblade as well as osteotome, the femur was removed easily.There is no cement on the back of the femoral implant when it was removed.Cement was removed from the distal femur and canal.Bony inventory after removal of the femoral component revealed aori 2a bone loss.The tibial component was found to be well fixed.Bony inventory after removal of cement of the tibia revealed mild-to-moderate bone loss.All soft tissue around the patellar button was cleared and it was noted to be loose.The patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
Pending investigation.Recall: z-0021-2022.
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, loss of range of motion, patellar loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information 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 1, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16732398
• Report Number: 1038671-2023-00673
• Device Sequence Number: 17810856
• Product Code: JWH
• UDI-Device Identifier: 10885862173409
• UDI-Public: 10885862173409
• 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: 2017
• Device Explanted Year: 2023
• 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): 12/31/2024

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: 08/03/2020
• Device Model Number: 02-012-44-1011
• Device Catalogue Number: 02-012-44-1011
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female