MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-03-0340 - logic cr femoral cem, right, sz 4.(b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(b)(6), 200-02-32 - three peg patella 32mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2018.Approximately 4 years and 1 month after the initial procedure the patient had a right knee revision on (b)(6) 2023.The patient has suffered the following injuries and complications: joint pain, joint swelling and stiffness, tissue damage, revision surgery, polyethylene wear and osteolysis.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 (b)(6) 2023: diagnosis: right total knee with polyethylene failure and resultant osteolysis there was a large effusion which was nonpurulent.No metalosis present.He had a hyperproliferative synovium which was brownish discoloration.They were able to remove the polyethylene and was certainly a fracture, pitting and delamination of the polyethylene on both the medial and lateral compartments.There was some osteolysis about the posterior medial femoral condyles but was not extensive.The tibia had a large lytic lesion about the anterior medial aspect of tibial plateau.No complications occurred throughout the case.The patient was awoken and transferred to the recovery room in stable condition.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.3(b)(4), and pending in the eastern district of new york.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
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 fracture or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 CR TIB INSERT SLOPE+, SZ 4, 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: kate jacobson ; 3523771140
• MDR Report Key: 17807706
• Report Number: 1038671-2023-02359
• Device Sequence Number: 17824522
• Product Code: JWH
• UDI-Device Identifier: 10885862174482
• UDI-Public: 10885862174482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 12/26/2024

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: 02/15/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
• Device Catalogue Number: 02-012-48-4009
• 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: 12/19/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2012
• 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 Age: 57 YR
• Patient Sex: Male