MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) - 02-010-01-0250 - logic femoral ps cem left sz 5 (b)(6) - 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t (b)(6) - 200-02-38 - three peg patella 38mm.The product associated with the reported event is within the scope of recall z-0021-2022; 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.
Event or Problem Description
*****09-oct-2024 additional information**** legal case ¿ usa (b)(6).Patient id: (b)(6) + left knee.It is reported via legal documentation that plaintiff underwent left knee replacement (b)(6) 2015 and revision left knee (b)(6) 2023.The patient has filed a short-form complaint in a coordinated action in (b)(6) county with master case no.(b)(6).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.***original summary*** experience report - usa.Patient id: (b)(6) lk rev.As reported, the patient had an initial left tka on (b)(6) 2015.The patient complained of pain and was revised on (b)(6) 2023 due to a loose femur and recalled poly.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Photos & x-rays: product not returning - chain of command.Due to recall hospital will not release.Ebi initial surgery: (b)(6) - 02-012-35-5015 - logic tibia ps mod insrt sz 5 15mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k033883.Concomitants: (b)(6) - 02-012-35-5015 - logic tibia ps mod insrt sz 5 15mm, (b)(6)- 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6)- 200-02-38 - three peg patella 38mm.
Event or Problem Description
It was reported that approximately 96 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, joint laxity, and pain.No further issues or complications were reported.No additional information is available.
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 tibial prosthesis wear.The root cause of the prosthesis wear cannot be confirmed by the provided images and clinical information, and devices were not available for evaluation.Additionally, a contributing factor to the reported wear may have been the result of the insert 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.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 15MM
• 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: 20418587
• Report Number: 1038671-2024-03916
• Device Sequence Number: 8222309
• Product Code: JWH
• UDI-Device Identifier: 10885862001955
• UDI-Public: 10885862001955
• 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: 2015
• 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): 03/13/2025

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: 06/08/2017
• Device Catalogue Number: 02-012-35-5015
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2009
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male