MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t, (b)(6), 02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm, (b)(6), 200-02-32 - three peg patella 32mm.Pending investigation.
Event or Problem Description
As reported via legal documentation the 74 y/o female patient had a left knee replacement on (b)(6) 2017.Approximately 4 years and 11 months after the initial procedure the patient had a left knee revision on (b)(6)2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report 30 sept 2022: diagnosis: polyethylene wear and loosening femoral component.Findings: there was found to be a clean wound with clear synovial joint fluid.There was found to be a well-fixed tibial component.There was visible evidence of polyethylene wear with the tibial polyethylene, as well as the patellar button polyethylene.The poly insert and the patellar button were removed.The femoral component was found to be loose from the cement mantle on the distal femur and was revised with a fully-cemented stemmed component.Ace wrap used.The patient was transferred to recovery in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17080334
• Report Number: 1038671-2023-01274
• Device Sequence Number: 15039310
• Product Code: JWH
• UDI-Device Identifier: 10885862173607
• UDI-Public: 10885862173607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 12/12/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
• Device Catalogue Number: 02-012-44-3511
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2012
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female