MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal team, approximately three years post initial tka, this (b)(6) male patient underwent a revision for an unknow reason.No additional information available.
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, left sz 2.5 (cat# 02-010-03-0225 / serial# (b)(4)); lgc tibial fit tray cem sz 2.5f / 3.5t (cat# 02-012-45-2535 / serial# (b)(4)) ; three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) as reported by the legal team, approximately three years post initial tka, this 53 y/o male patient underwent a revision for an unknow reason.No additional information available.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 subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Event or Problem Description
Additional information - revision op report diagnosis: polyethylene failure.After we removed the tibial tray, you could easily see medial polyethylene wear and loss and damage including the posterior lip of the polyethylene, both medially and laterally.The majority of the polyethylene damage was medially, but it already started occurring laterally as well.After removal, he had a large cystic cavltaceous lesion about the lateral femoral condyle.He had a cortical bone, it was still intact, which incorporated the lateral epicondyle and due to this importance, i did feel that necessary to place three 3.5 screws into the lateral femoral condyle as support for the cement.He also had a medial femoral condyle lesion, which was not as large, in that way, my plan was to just fill with bone cement.
Additional Manufacturer Narrative
D10.Concomitants: 02-010-03-0225, 5620973 - logic cr femoral cem, left sz 2.5.02-012-45-2535, 5118501 - lgc tibial fit tray cem sz 2.5f / 3.5t.200-02-32, 5620069 - three peg patella 32mm.H3: investigation results - the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor to the wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14210525
• Report Number: 1038671-2022-00466
• Device Sequence Number: 19922786
• Product Code: JWH
• UDI-Device Identifier: 10885862159144
• UDI-Public: 10885862159144
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2023

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: 08/16/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-47-2509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 12/18/2023
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 09/23/2022; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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: 53 YR
• Patient Sex: Male