MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM; SEE H10

Model Number	02-012-51-4013
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Cyst(s) (1800); Failure of Implant (1924)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented.Pending investigation.
Event or Problem Description
As reported by the legal team; second revision operative report: preoperative diagnosis- failed total left knee arthroplasty.58 year old male with end-stage osteoarthritis of the left knee, status post total knee arthroplasty.He has a failure of the tibial component with cystic formation.Kneecap was everted, tricompartmental osteoarthritic changes were noted.Patella was evaluated, was pristine and was not removed.Osteophyte from the superior pole of the patella was removed.Extensive debridement and synovectomy sharply done.The femur was removed.Minimal bone loss was encountered.There was excellent fixation of the component, but they were able to remove it with the saw blade and thin osteophyte.The surgeon then turned attention to the tibia and using a similar system, the tibia was loose.Using the osteotome and saw, the surgeon was able to remove it with this trying to limit the amount of bone loss.There was a large cyst on the proximal tibia that had been seen on the x-ray.This was debrided and removed.Tibial and femoral components were replaced.,11mm insert used.Sterile dressing was applied, the patient was awakened and taken to the recovery room in good condition.Second revision is approximately 9 years post first revision surgical procedure.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of both patient-related conditions and an insufficient bond between the tibial tray and the bone, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the explanted devices were not returned for evaluation, and radiographs and photographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision reported may have been the result of both patient-related conditions and an insufficient bond between the tibial tray and the bone, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the explanted devices were not returned for evaluation, and radiographs and photographs were not provided.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.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b.The revision reported may have been the result of both patient-related conditions and an insufficient bond between the tibial tray and the bone, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the explanted devices were not returned for evaluation, and radiographs and photographs 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 4, 13MM
• Common Device Name: SEE H10
• 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
• MDR Report Key: 16687799
• Report Number: 1038671-2023-00592
• Device Sequence Number: 12290026
• Product Code: JWH
• UDI-Device Identifier: 10885862230508
• UDI-Public: 10885862230508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2025

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: 02/18/2018
• Device Model Number: 02-012-51-4013
• Device Catalogue Number: 02-012-51-4013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 02/20/2025; 03/17/2025
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 08/08/2023; 02/26/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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): 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: 58 YR
• Patient Sex: Male