MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM; TIB INSERT IMPL CRC, SZ 3, 13MM

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Event or Problem Description
As reported, the 78 y/o male patient had a revision for pre-mature wear on the poly-ethylene.Replaced poly with a new, pre-packaged poly.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photo received.The device is not available for evaluation.
Additional Manufacturer Narrative
Section d6a: implanted date.Additional information, including the product investigation, will be submitted within 30 days of receipt section d1: brand name.Section d4:model number, catalog number, serial number, expiration date, unique identifier (udi) #.Section h4: device manufacture date.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of third body wear, rotational mismatch between the femoral and tibial components, and/or patient related conditions which led to wear of the tibial insert.However, this cannot be confirmed because the component 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.Updated codes: e and g.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be third body wear, rotational mismatch between the femoral and tibial components, or inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information 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 TIB INSERT IMPL CRC, SZ 3, 11MM
• Common Device Name: TIB INSERT IMPL CRC, SZ 3, 13MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14656161
• Report Number: 1038671-2022-00674
• Device Sequence Number: 5574843
• Product Code: JWH
• UDI-Device Identifier: 10885862230416
• UDI-Public: 10885862230416
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/12/2025

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: 01/02/2018
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM
• Device Catalogue Number: 02-012-51-3011
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 01/20/2023; 01/02/2025; 02/11/2025
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 06/21/2022; 02/06/2023; 01/06/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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): Yes
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male