MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC FEMORAL PS CEM LEFT SZ 2.5

Model Number	02-010-01-0225
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant medical products- lgc tibial fit tray cem sz 2.5f / 2.5t (cn: 02-012-45-2525, sn: (b)(4).Size 2.5/13mm ps insert (cn: 02-012-35-2513, sn: (b)(4).
Event or Problem Description
Case was originally done in 2013 by dr.(b)(6).Patient had sufficient bone loss on the tibia.As well as, distal/posterior of the femur.Causing losing of the components.Also, there was a significant pitting of the 2.5/13mm insert.(b)(6) revised everything as well as used a tibia cone.Osslix was used to fill in the tibia defect.Patient was alert and well when leaving the operating room.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision was likely the result of an insufficient bond between the implants and the bone, likely due to the patient¿s reported bone loss, which led to aseptic (non-infected) loosening of the tibial and femoral components.It is unclear if the observed prosthesis wear may have contributed to the reported revision.However, the wear was likely the result of third body wear, not properly seating the tibial insert, and/or malalignment between the femoral and tibial components.Concomitant medical device(s): - lgc tibial fit tray cem sz 2.5f / 2.5t (cn: 02-012-45-2525, sn: (b)(6)) - size 2.5/13mm ps insert (cn: 02-012-35-2513, sn: (b)(6)).
Event or Problem Description
Initial implant date of the left knee was done in 2013.Patient had sufficient bone loss on the tibia.As well as, distal/posterior of the femur.Causing losing of the components.Also, there was a significant pitting of the 2.5/13mm insert.The surgeon revised everything as well as used a tibia cone.Osslix was used to fill in the tibia defect.Patient was alert and well when leaving the operating room.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC FEMORAL PS CEM LEFT SZ 2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9208783
• Report Number: 1038671-2019-00532
• Device Sequence Number: 10848994
• Product Code: JWH
• UDI-Device Identifier: 10885862001139
• UDI-Public: 10885862001139
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 12/06/2017
• Device Model Number: 02-010-01-0225
• Device Catalogue Number: 02-010-01-0225
• Device Lot Number: 05020871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 94