MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 4, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 69 yo male patient, initial left knee implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2024, approximately 7 years 9 months post the initial procedure.The patient was revised due to femur loosening, osteolysis and poly wear.All components were removed and were replaced by a competitor¿s revision knee.There were no device breakages or surgical delays during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.They were disposed of by the hospital.No further information.
Additional Manufacturer Narrative
Section d10: concomitant products: - lgc tibial fit tray cem sz 4f / 5t (cat# 02-012-45-4050 / serial# (b)(6).- logic cr tib insert std, sz 4, 9mm (cat# 02-012-47-4009 / serial# (b)(6) - three peg patella 38mm (cat# 200-02-38 / serial# (b)(6).
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been the result of femoral loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.The polyethylene wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, instability, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause for 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.Also, the most probable root cause for the event ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.Furthermore, the most probable root cause for the event ¿loosening ¿ femoral¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
The revision reported may have been the result of femoral loosening, prosthesis wear, and osteolysis.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.The polyethylene wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, instability, patient-related conditions, 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 4, 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
• MDR Report Key: 19110375
• Report Number: 1038671-2024-00841
• Device Sequence Number: 20922659
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• 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: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024

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: 02/02/2023
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 4, 9MM
• Device Catalogue Number: 02-012-47-4009
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 12/04/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/31/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0585-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 90 KG