MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t 5216452.02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5 5218839.201-00-02 - gps daily rental fee unassigned.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2018.The patient started experiencing pain, swelling, instability and an inability to bear weight on left knee.Approximately 4 years and 9 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.This is believed to be due to accelerated polyethylene wear and early aseptic loosening.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.1st investigation: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the complaint cannot be conclusively determined; insufficient information.The patient has filed a complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.(b)(4), and pending in the eastern district of (b)(6).Per the transfer order creating this multidistrict litigation, ¿plaintiffs allege that their knee or hip replacement devices failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
Additional Manufacturer Narrative
Investigation results - the revision reported was likely the result of a combination of polyethylene wear and aseptic loosening between the porous femoral component and the bone secondary to weakened biologic integration.The femoral loosening may have been the result of particle-induced osteolysis or patient-related conditions.Not resurfacing the patella at the time of the original surgery may have contributed to the reported instability.The prosthesis wear may have been the result of axial rotation mismatch between the femoral and tibial components, third body wear, instability, or any combination of these possibilities.However, the contributions of each to the sequence of events cannot be confirmed as the device(s) were not available for evaluation and images/radiographs were not provided.A contributing factor to the polyethylene wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Initial submission: all fields in section f should be blank, this is a manufacturer's report.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 9MM
• 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: miguel sosa ; 3523771140
• MDR Report Key: 17850184
• Report Number: 1038671-2023-02405
• Device Sequence Number: 20555474
• Product Code: JWH
• UDI-Device Identifier: 10885862173515
• UDI-Public: 10885862173515
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 07/24/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 9MM
• Device Catalogue Number: 02-012-44-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• 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: A
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female