MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately four years post initial tka, this (b)(6) female patient experienced aseptic tibial loosening.Patient came in with increased pain.X-rays show loosening of tibial component with medial & posterior subsidence and lucency around component.On (b)(6) 2021, patient saw surgeon and knee was aspirated and sent for cultures.On (b)(6) 2021, it's concluded negative for infection.A revision was done on (b)(6) 2021 using smith-nephew products.The event is unlikely related to the device buy definitely related to the procedure.
Additional Manufacturer Narrative
Concomitant medical products: logic cr tib insert std, sz 4, 13mm (cat# 02-012-47-4013).Logic cr femoral cem, right, sz 4 (cat# 02-010-03-0340).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Concomitant medical products: logic cr tib insert std, sz 4, 13mm (cat# 02-012-47-4013 / serial# (b)(6)).Logic cr femoral cem, right, sz 4 (cat# 02-010-03-0340 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of an insufficient bond between the tibial tray and the bone, poor bone quality, patient-related conditions, or any combination of these possibilities, which led to aseptic (non-infected) tibial loosening and tibial subsidence.However, this cannot be confirmed as the devices and pre-revision x-rays were not available for evaluation.The most probable root cause associated with the reported event of "loosening - tibial¿ is associated with weakened integration of the tibial component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root cause associated with the reported event of "tibial subsidence¿ is associated with a tibial tray that subsides into the prepared tibia further than expected.This typically occurs post-operatively.
Additional Manufacturer Narrative
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 tibial loosening or due to inclusion of the polyethylene in the packaging recall.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, radiographs, and relevant clinical information 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: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13426763
• Report Number: 1038671-2022-00145
• Device Sequence Number: 20159632
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2025

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: 06/16/2025
• Device Model Number: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
• Device Catalogue Number: 02-012-45-4040
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/25/2022; 05/27/2022; 03/03/2025
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/11/2022; 06/19/2022; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: Black Or African American