MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM; SEE H10

Model Number	02-012-44-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification that on october 29, 2014, the patient underwent a right total knee replacement surgery where she was implanted with an optetrak logic psc polyethylene tibial insert (serial #: (b)(4)).Then, on (b)(6) 2017 , approximately 2 years 6 months post implant, she underwent a right knee revision surgery due to accelerated and preventable wear of the optetrak logic polyethylene tibial insert and was implanted with an optetrak logic psc polyethylene tibial insert.It is stated that the patient experiences pain in both of her knees and will likely require re-revision surgeries in both knees to remove the optetrak devices currently implanted.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer concomitants: 02-010-01-0320 - logic femoral ps cem right sz 2; 3647194; 02-012-41-2020 - logic tibia traptray cem sz 2f/2t; 2912306; 200-02-29 - three peg patella 29mm; 3709608.Pending investigation.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of polyethylene wear as stated in the legal documentation.The extent and root cause of the polyethylene wear cannot be determined as the device was not available for evaluation and radiographs, photographs, or operative notes were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16703995
• Report Number: 1038671-2023-00621
• Device Sequence Number: 20263718
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 09/02/2022
• Device Model Number: 02-012-44-2011
• Device Catalogue Number: 02-012-44-2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female