MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case: patient id: (b)(6).Patient complained of pain.Loose femur.Experience report - usa it was reported that a 71 yo male patient, initial right knee.Implant date, (b)(6) 2014, was revised on (b)(6) 2023, approximately 8 years 10 months post the initial procedure, the patient complained of pain.Loose femur indicated on the report provided.Patient was last known to be in stable condition following the event.No device returns anticipated.Reason reported, ¿chain of command.Due to recall hospital will not release implants.¿ no further information.Patient revised to exactech devices? yes.No breakage of device or surgical delay/prolongation.No other patient information/medical history reported.Product not returning - chain of command.Due to recall hospital will not release implants.The revision reported in case-2023-00007604 may have been the result of polyethylene wear, femoral loosening, and pain.The prosthesis wear may have been the result of malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities.The aseptic (non-infected) femoral loosening may have been the result of both patient-related conditions and an insufficient bond between the femoral component and the bone.However, this cannot be confirmed as the device(s) were not returned for evaluation and operative notes were not provided.(b)(6), 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm: serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6), 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm: serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k033883.Concomitants: (b)(6), 02-010-01-0250 - logic femoral ps cem left sz 5.(b)(6), 02-010-01-0350 - logic femoral ps cem right sz 5.(b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6), 200-02-41 - three peg patella 41mm.(b)(6), 200-02-41 - three peg patella 41mm.(b)(6) 2023, (b)(6) ¿ upon investigation it was discovered that (b)(4) is a duplicate of case- 2023-00007604.Concomitant components identified as identical for both cases.Additional/new information will be captured in case-2023-00007604 and reported under mfr# 1038671-2023-00399.Case- 2023-00009645 has been closed.(b)(6) 2024, (b)(6), rn-there is no information to alter the reportability assessments/severity/investigation results.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0250 - logic femoral ps cem left sz 5.(b)(6), 02-010-01-0350 - logic femoral ps cem right sz 5.(b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6), 200-02-41 - three peg patella 41mm.(b)(6), 200-02-41 - three peg patella 41mm.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be femoral loosening and inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 TIBIA PS MOD INSRT SZ 5 11MM
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20189385
• Report Number: 1038671-2024-03439
• Device Sequence Number: 20611408
• Product Code: JWH
• UDI-Device Identifier: 10885862001931
• UDI-Public: 10885862001931
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 11/24/2018
• Device Catalogue Number: 02-012-35-5011
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2010
• 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: Required Intervention; Hospitalization
• Patient Sex: Male