MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Joint Laxity (4526); Joint effusion (4849)
Date of Event	09/22/2022
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)2018.Approximately 4 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.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.No additional information is available.Revision op report on (b)(6) 2022.Diagnosis: failed right knee replacement secondary to wear of the bearing surface findings: found exuberant foreign body reaction, a gross contamination of the synovium with polyethylene debris, and very significant wear of the polyethylene insert with tremendous loss of substance from the medial aspect of the implant.The other implants were well fixed and in good condition.The patient was awakened and taken to the recovery room in stable condition.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0335 - logic femoral ps cem right sz 3.5.(b)(6), 02-012-41-3545 - logic tibia traptray cem sz 3.5f/4.5t.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 201-78-12 - holding pin lg head sharp point med 2pk.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.D10: concomitants: (b)(6) 02-010-01-0335 - logic femoral ps cem right sz 3.5 (b)(6) 02-012-41-3545 - logic tibia traptray cem sz 3.5f/4.5t (b)(6) 200-02-38 - three peg patella 38mm (b)(6) 201-78-12 - holding pin lg head sharp point med 2pk the following sections were updated: g1, h6 the following sections were corrected: b1, b2, h6 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability 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 TIBIA IMPLANT PSC INSERT, SZ 3.5, 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17500162
• Report Number: 1038671-2023-01926
• Device Sequence Number: 11398898
• Product Code: JWH
• UDI-Device Identifier: 10885862173621
• UDI-Public: 10885862173621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2019
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM
• Device Catalogue Number: 02-012-44-3515
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown