MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-012-47-5009 - logic cr tib insert std, sz 5, 9mm: 3850485 200-02-38 - three peg patella 38mm 4848517.
Event or Problem Description
As reported, approximately 6 years post op initial left tsa, this 60 y/o male patient was revised.The patient was revised due to femoral loosening and osteolysis as a result of poly wear.The patient was revised to a size 5 femoral component and a size 5 13mm tibial insert.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of femoral loosening and tibial insert wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and bone.The tibial insert wear may have been due to malalignment between the implants, third body wear, patient related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation.*the following sections have corrected information: (d1) brand name.(d4) catalog number, expiration date, serial number, unique identifier (udi) #.(h4) device manufacture date.
Additional Manufacturer Narrative
Report number: 1038671-2023-03080 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were corrected: b2 d4: expiration date d10 concomitants: 200-02-38 - three peg patella 38mm (b)(6), 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t (b)(6).H4 the revision reported was likely the result of femoral loosening and tibial insert wear.The aseptic (non-infected) loosening was likely the result of an insufficient bond between the femoral component and bone.The tibial insert wear may have been due to malalignment between the implants, third body wear, patient related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available 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 CR TIB INSERT STD, SZ 5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20057238
• Report Number: 1038671-2024-03058
• Device Sequence Number: 18102888
• Product Code: JWH
• UDI-Device Identifier: 10885862174543
• UDI-Public: 10885862174543
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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: 02/03/2023
• Device Catalogue Number: 02-012-47-5009
• 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: 12/10/2023
• Supplement Date Received by Manufacturer: 10/18/2024; 10/18/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/06/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 120 KG