MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 1 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in person site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.This patient (549) was implanted with a 02-012-35-1011-inserto tibial logic ps 1, 11 mm, serial number (b)(4) on (b)(6) 2014.The insert was manufactured on 20-mar-2014 and was packaged in a vacuum bag with no evoh.The insert was manufactured on 20-mar-2014 and was six months shelf age at the time of implant.Approximately nine years post implantation, the patient is pending revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
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 and h6 have been updated accordingly.(h3 the prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty.Subsequently, the patient experienced wear of the tibial insert.As a result, the patient is scheduled for a knee revision on a future date.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b3, b5, d8, g1, g2, h6 - health effect - clinical code, impact code, investigation findings, investigation conclusions, h7 and h11.B3: unknown date.The prosthesis wear reported may have been due to third body wear, patient-related conditions, instability, and/or malalignment between the femoral and tibial components.However, this cannot be confirmed as the devices were not available for evaluation 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 PS MOD INSRT SZ 1 11MM
• 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: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16950602
• Report Number: 1038671-2023-01007
• Device Sequence Number: 6850837
• Product Code: JWH
• UDI-Device Identifier: 10885862001696
• UDI-Public: 10885862001696
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 03/19/2022
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 1 11MM
• Device Catalogue Number: 02-012-35-1011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 02/27/2026
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/28/2023; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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: 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; Other
• Patient Sex: Unknown