MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Discomfort (2330); Osteolysis (2377)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6)-2023-00781 d10: concomitant devices (b)(6)- 02-012-35-2009 - logic tibia ps mod insrt sz 2 9mm, (b)(6)- 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t, (b)(6)- 200-02-35 - three peg patella 35mm, two non-exactech saw blades.The reason for the revision reported in case-(b)(4) cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of 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 and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported by legal notification, this female patient had bilateral tkas on (b)(6) 2018.She started to develop some discomfort in her left knee and radiographs obtained in (b)(6)2022 demonstrated dissolution of the polyethylene component medially, as well as faint osteolysis.Revision was advised due to synovitis and discomfort.More recent radiographs demonstrated more aggressive osteolysis with probable loosening of the femoral component.The patient underwent revision surgery on (b)(6)2023.Extensive synovitis was noted.The polyethylene insert was removed and it was noted that there was extensive wear medially and about the post with complete delamination of the plastic.The loose fragments of plastic were noted throughout the knee.The femoral component was easily removed and debonded completely from the underlying cement.A complete debridement of the knee was performed.(b)(6), 02-012-35-2009 - logic tibia ps mod insrt sz 2 9mm serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k033883 concomitants: (b)(6)- 02-010-01-0220 - logic femoral ps cem left sz 2.(b)(6)- 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t.(b)(6)- 200-02-35 - three peg patella 35mm.(b)(6)- -203-96-01 - (11-2222) saw blade new stryk (.050).(b)(6)- 203-96-03 - (11-2216) saw blade new stryker (.050).

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2
• 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 ct; gainesville, FL 32653
• MDR Report Key: 21020945
• Report Number: 1038671-2024-05004
• Device Sequence Number: 14445283
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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: 06/04/2023
• Device Catalogue Number: 02-010-01-0220
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 12/26/2024
• Date Device Manufactured: 06/06/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female