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

Model Number	LOGIC TIBIA FIN TRAY CEM SZ 4F/4T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(4)).Logic femoral ps cem right sz 4 (cat# 02-010-01-0340 / serial# (b)(4)).Three peg patella 38mm (cat# 200-02-38 / serial# (b)(4)).Trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 11 yrs postop the initial left tka, this (b)(6) y/o male patient had a knee revision due to tibial was loose and the poly was worn.Metallosis was evident.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
Section d10: concomitant medical products: logic tibia ps mod insrt sz 4 13mm (cat# 02-012-35-4013 / serial# (b)(6)).H3: the revision reported was likely the result of a degeneration of the bond between the tibial tray and the bone/bone cement, which led to aseptic (non-infected) tibial loosening and subsequent metallosis.The loosening and movement of the tibial insert within the tibial tray may have led to instability, slight malalignment, and an increase in cement and bone particles in the joint space and resulted in fatigue polyethylene wear.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 ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: LOGIC TIBIA FIN 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: 12908826
• Report Number: 1038671-2021-00646
• Device Sequence Number: 4751332
• Product Code: JWH
• UDI-Device Identifier: 10885862002730
• UDI-Public: 10885862002730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 04/30/2015
• Device Model Number: LOGIC TIBIA FIN TRAY CEM SZ 4F/4T
• Device Catalogue Number: 02-012-39-4040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male