MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 4, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CC FEMORAL SIZE 4, RIGHT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants medical product(s): (b)(4) 02-010-06-0541 - logic post.Aug.Block size 4, 5mm; (b)(4) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(4) 02-012-60-1212 - logic stem ext 12mm x 120mm; (b)(4) 02-012-60-1612 - logic stem ext 16mm x 120mm; (b)(4) 02-012-61-6000 - logic offset stem ext coupler 6mm; (b)(4) 200-02-38 - three peg patella 38mm; (b)(4) 208-06-04 - cc distal fem augment sz 4, 10mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Legal case - (b)(6) (b)(4).Related case (b)(4) (b)(4).Email from legal: per a report from the legal department, the patient had an initial right knee implanted on (b)(6) 2013.The patient had two revisions of the right knee (b)(6) 21 and (b)(6) 22 ***all 3 op reports are attached.Op report (b)(6) 2022.Pre & post op diagnosis: failed total right knee replacement indications: patient had severe pain due to failed aseptic loosening of total right knee replacement.Pt has failed conservative treatment and wished to undergo operative intervention.Risks, benefits, and alternatives discussed with patient.Despite potential risks, they wished to proceed with the operative intervention.Intraoperative findings: loose femoral implant - removed easily with minimal bone loss but concerned for bone quality distal femur.I elected to sue femoral cone.Tibial implant was very solid and well fixed - backslap device and osteotomes were used but stem would not budge - cortical window distal to the stem allowed me to hit the stem tip and knock it out retrograde.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.5974191 02-010-06-0340 - logic cc femoral size 4, right.Pma-510k: k150890.Concomitants: (b)(4) 02-012-65-4013 - logic cc tib insert size 4, 13mm; note: the serial number (b)(4) is not affected by the recall; (b)(4) 02-010-06-0541 - logic post.Aug.Block size 4, 5mm; (b)(4) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(4) 02-012-60-1212 - logic stem ext 12mm x 120mm; (b)(4) 02-012-60-1612 - logic stem ext 16mm x 120mm; (b)(4) 02-012-61-6000 - logic offset stem ext coupler 6mm; (b)(4) 200-02-38 - three peg patella 38mm; (b)(4) 208-06-04 - cc distal fem augment sz 4, 10mm.
Additional Manufacturer Narrative
Associated mfr # 1038671-2024-05006.This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening.The reported prosthesis wear and femoral loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs 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 CC FEMORAL SIZE 4, RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16725637
• Report Number: 1038671-2023-00660
• Device Sequence Number: 12791311
• Product Code: JWH
• UDI-Device Identifier: 10885862265722
• UDI-Public: 10885862265722
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 04/17/2024
• Device Model Number: LOGIC CC FEMORAL SIZE 4, RIGHT
• Device Catalogue Number: 02-010-06-0340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male