MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 7.5 years post initial right tka, the 71 y/o male patient had a revision due to poly recall scenario.The poly was delaminated, broken and particles had irritated surrounding tissue.The patient was revised to exactech devices.Surgeon implanted cc femoral and cc tibial components after crc implants were removed.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and images received.The devices are not available for evaluation.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear due to mechanical overload on the posterior medial edge of the tibial insert secondary to the overall tibial slope and potential ligamentous/soft tissue changes resulting in rotational malalignment and/or uneven in-vivo loading between the tibial and femoral components.However, this cannot be confirmed as the device was not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear due to mechanical overload on the posterior medial edge of the tibial insert secondary to the overall tibial slope and potential ligamentous/soft tissue changes resulting in rotational malalignment and/or uneven in-vivo loading between the tibial and femoral components.However, this cannot be confirmed as the device 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 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 18563538
• Report Number: 1038671-2024-00120
• Device Sequence Number: 18173798
• Product Code: JWH
• UDI-Device Identifier: 10885862230560
• UDI-Public: 10885862230560
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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: 01/01/2018
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM
• Device Catalogue Number: 02-012-51-5009
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 11/19/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 05/08/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male