MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately two years post initial left side tka, the female patient had a revision due to poly wear.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays & photos.The device is not available for evaluation due to hospital disposed the device.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the revision reported may have been due to third body wear, patient- related conditions, instability, and/or malalignment between the femoral and tibial components, which lead to prosthesis wear.However, this cannot be confirmed because the tibial insert was not returned for evaluation.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.
Additional Manufacturer Narrative
(h3) the revision reported may have been due to third body wear, patient- related conditions, instability, and/or malalignment between the femoral and tibial components, which lead to prosthesis wear.However, this cannot be confirmed because the tibial insert was not returned for evaluation.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d4: model number.D10 concomitant devices: (b)(4) 02-012-45-3535 lgc tibial fit tray cem sz 3.5f / 3.5tt.(b)(4) 02-010-04-0235 logic cr femoral por, left, sz 3.5.(b)(4) 200-02-38 three peg patella 38mm.The revision reported may have been due to third body wear, patient- related conditions, instability, and/or malalignment between the femoral and tibial components, which lead to prosthesis wear.However, this cannot be confirmed because the tibial insert was not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3.5, 9MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15928223
• Report Number: 1038671-2022-01573
• Device Sequence Number: 6722826
• Product Code: JWH
• UDI-Device Identifier: 10885862230447
• UDI-Public: 10885862230447
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 08/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 02-012-51-3509
• 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: 11/20/2022
• Supplement Date Received by Manufacturer: 02/23/2023; 02/23/2023; 01/27/2025
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/15/2023; 04/16/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5TT; LOGIC CR FEMORAL POR, LEFT, SZ 3.5; THREE PEG PATELLA 38MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female