MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related: mfr #1038671-2024-00812 report 1 of 2.Additional manufacturer narrative- report 2 of 2.D4.It is unknown which device was implanted: sn (b)(6), 02-012-47-3509 - logic cr tib insert std, sz 3.5, 9 mm or sn (b)(6), 02-012-47-3509 - logic cr tib insert std, sz 3.5, 9 mm [both serial numbers for tibial insert are part of recall # z-0021-2022].D10.Concomitants: 2865251 02-010-03-0235 - logic cr femoral cem, left, sz 3.5; 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t; 200-02-38 - three peg patella 38mm; 3870846 201-46-10 - holding pin headless 3" (4 pk).H3.Investigation results- the revision reported was likely the result of polyethylene wear, femoral loosening and osteolysis as stated in the operative notes.The prosthesis wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the reason for the reported prosthesis wear could not be confirmed as the devices were not returned for evaluation, and images/radiographs were unable to be obtained.The occurrence rate is ¿very low,¿ and the identified risk related to this failure is listed in the product labeling and is within the level assessed in the current risk management files.Two tibial inserts were invoiced for this patient¿s index surgery because it was a bilateral case.Since it is not possible to determine which of these devices were implanted in the patient¿s left knee, manufacturing data for both invoiced tibial inserts were reviewed.Sn: (b)(6)- exactech is not aware of any other complaints involving parts from this tibial insert¿s manufacturing lot of (b)(4) units.This specific tibial insert was packaged for approximately 3 years before being implanted.Sn: (b)(6)- exactech is not aware of any other complaints involving parts from this tibial insert¿s manufacturing lot of (b)(4) units.This specific tibial insert was packaged for approximately 2 years and 9 months before being implanted.These devices are used for treatment not diagnosis.There is no additional information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty and then experienced a revision surgical procedure approximately 8 years and 1 month after initial implant.Revision operative report-postoperative diagnosis: femoral loosening and extensive poly wear osteolysis.The patient was revised to competitor's devices.Patient developed persistent left knee pain and swelling, evidence of osteolysis and poly wear synovitis.There was moderate clear effusion and extensive poly wear synovitis.Extensive pitting and wear over portions of poly, consistent as the source of the osteolysis and wear.The femur has posterior osteolysis with large areas of loosening.The patellar component was maintained.The patient was awoken and transferred to pacu in stable condition.No complications.No images were provided.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1/d2a/d2b, h6 (b, c, d codes).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 3.5, 9 MM
• 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19578116
• Report Number: 1038671-2024-02051
• Device Sequence Number: 17138854
• Product Code: JWH
• UDI-Device Identifier: 10885862159243
• UDI-Public: 10885862159243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 03/25/2025

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 Catalogue Number: 02-012-47-3509
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male