MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six years post initial right tka, this female patient poly was being revised due to loose femur.Patient had a loose femur and slightly worn poly.Patient was revised to (b)(6).There was no breakage of a device and no surgical delay/prolongation.Patient was last known to be in stable condition.Sales rep was unable to obtain photos/x-rays.The device will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, d9, d10, g3, g6, h2, h3, h4 and h6 have been updated accordingly.Section d10: concomitant medical products.Logic tibia ps mod insrt sz 2.5 13mm (cat# 02-012-35-2513 / serial# (b)(6)).(h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The loosening and movement of the tibial insert within the tibial tray may have led to instability, malalignment, and an increase in cement and bone particles in the joint space and resulted in polyethylene wear.The most probable root cause associated with the reported event of "loosening - femoral¿ is associated with weakened integration of the femoral 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.Section d1: brand name.Section d4: model number, catalog number, unique identifier (udi) # section g4: pma/510(k)number.
Additional Manufacturer Narrative
1038671-2024-03647, 1038671-2024-03646.This follow-up report is being submitted to relay additional and/or corrected information.D10: concomitant devices: (b)(6) 02-010-01-0325 - logic femoral ps cem right sz 2.5.(b)(6) 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t.(b)(6) 200-02-29 - three peg patella 29mm.(b)(6) 521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(6) 203-96-43 - 11-4137 sys 6 90x13x1.19.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03647, 1038671-2024-03646.The revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The loosening and movement of the tibial insert within the tibial tray may have led to instability, malalignment, and an increase in cement and bone particles in the joint space and resulted in polyethylene wear.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13967587
• Report Number: 1038671-2022-00336
• Device Sequence Number: 5053270
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 11/14/2024
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 10/05/2022; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• 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: LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T; SEE H11.; SRYKER SYS 6 90X13X1.19; THREADED PIN SIZE 3.0 COLLARLESS 2PK; THREE PEG PATELLA 29MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female