MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-35-2511
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 78 y/o female patient has had a total right knee revision due to femoral loosening.Patient was last known to be in stable condition following the event.Devices will not be returning, hospital disposed of them.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-010-01-0225 - logic femoral ps cem left sz 2.5, 2887011; 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t, 3706015; 200-02-32 - three peg patella 32mm, 3000676; 204-34-02 - fluted stem extension 25l x 14 mm 3726290.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported in was likely the result of patient-related conditions, an insufficient bond between the implant and the bone, or a combination of these possibilities, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4, d6a, h4, h6: clinical code, types of investigation, investigation findings, investigation conclusions.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2.5
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15484037
• Report Number: 1038671-2022-01165
• Device Sequence Number: 1870156
• Product Code: JWH
• UDI-Device Identifier: 10885862001139
• UDI-Public: 10885862001139
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2026

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: 04/04/2019
• Device Model Number: 02-012-35-2511
• Device Catalogue Number: 02-010-01-0225
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 05/11/2023; 01/09/2026; 02/02/2026
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 05/17/2023; 01/22/2026; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female