MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	06/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2016.Device has not been explanted.On (b)(6) 2022, the patient contacted the physician and reported swelling and pain on the lateral aspect of his right knee.He requested a diagnostic work-up of his right knee.The doctor's office recommended that the patient continue with the plan to surgically revise his left knee before beginning work up on the right knee.Specifically, he was informed that he should wait to perform a work up of his right knee until after his left knee surgery to ensure up to date imaging and testing is obtained and to ensure that his left knee healed enough to pursue revision right knee surgery if necessary.The patient was ordered to take anti-inflammatories to help manage the pain.As to his right knee, the patient has experienced pain and discomfort from over-use/over-compensating.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.Mdl no.(b)(4).The patient has filed a short-form 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
D10: concomitants: (b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4.(b)(6), 02-012-41-4040 - logic tibia traptray cem sz 4f/4t.Pending investigation.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusions manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
• 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 ; 3523771140
• MDR Report Key: 17816844
• Report Number: 1038671-2023-02376
• Device Sequence Number: 6100868
• Product Code: JWH
• UDI-Device Identifier: 10885862173669
• UDI-Public: 10885862173669
• 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: 2016
• Serviced by Third Party (Y/N): N
• 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): 10/16/2024

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: 05/22/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
• Device Catalogue Number: 02-012-44-4015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2014
• 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: Unknown