MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement and then approximately 8 years and 9 months after the initial procedure the patient had a left knee revision.Revision operative report -complications: interop tibia fracture during extraction of tibial component [sn (b)(6), 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f/3.5t] reported in mfr # 1038671-2023-02182.Postoperative diagnosis: post-op diagnosis: pain due to hip joint prosthesis, initial encounter, localized swelling, mass and lump, lower limb, left.Revised to competitor¿s devices.It was noted that the tibial component was well fixed but easily separated from the bone cement interface.Noted that the femoral component was loose.The patella was also assessed, and it was felt that while the patella was thin, there was significant poly wear to the patellar component and revision was necessary.A soft compression dressing was applied, and a knee immobilizer was placed.Disposition: plan for pacu - hemodynamically stable.Condition: stable.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.
Additional Manufacturer Narrative
Related: mfr #1038671-2023-01594.Report 1 of 3.Mfr #1038671-2023-02182.Report 2 of 3.Additional manufacturer narrative- report 3 of 3.D10.Concomitants: (b)(6), 02-012-35-3509 - logic tibia ps mod insrt sz 3.5 9mm.(b)(6), 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f/3.5t.(b)(6), 201-78-99 - 2pk, schanz pin 4mmx130mmx40mm thrd.H3.Investigation results- 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 extent and root cause of the femoral loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided for review.The device history record (dhr) for this femoral component was reviewed, and all components were accepted with conformance to the device requirements.The occurrence rate is considered ¿very low.¿.The risk documents were reviewed and are appropriate.H6- 4581 for lump/mass.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: LOGIC
• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19580452
• Report Number: 1038671-2024-02057
• Device Sequence Number: 3266444
• Product Code: JWH
• UDI-Device Identifier: 10885862001153
• UDI-Public: 10885862001153
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 06/15/2018
• Device Catalogue Number: 02-010-01-0235
• 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: 06/08/2023
• Initial Report FDA Received Date: 06/21/2024
• Date Device Manufactured: 10/13/2013
• 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: 69 YR
• Patient Sex: Male