MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC FEMORAL PS CEM RIGHT SZ 1

Model Number	02-010-01-0310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device: (cn: 02-012-45-1010, sn: unk) logic tibial fit tray cem size 1f / 1t.(cn: 02-012-44-1009, sn: unk) logic tibial ps insert, size 1, 9mm.
Event or Problem Description
As reported, approximately 6 years postop the initial tight tka, this female, patient was revised due to osteolysis.The patient has a history of osteoarthritis.The patient required a distal femoral replacement.Patient was last known to be in stable condition following the event.Device to de returned.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event reported based on review of all available information, there is no evidence of the contribution of the devices to the experience reported and it could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.The cause of the revision could not be conclusively determined due to the revision reported was not provided; however, it is most likely the result of the patient¿s underlying condition.Concomitant device: (cn: 02-012-45-1010, sn: unk) logic tibial fit tray cem size 1f / 1t (cn: 02-012-44-1009, sn: unk) logic tibial ps insert, size 1, 9mm.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC FEMORAL PS CEM RIGHT SZ 1
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10561019
• Report Number: 1038671-2020-00543
• Device Sequence Number: 14158670
• Product Code: JWH
• UDI-Device Identifier: 10885862001207
• UDI-Public: 10885862001207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D034553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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 Model Number: 02-010-01-0310
• Device Catalogue Number: 02-010-01-0310
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1