MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 9MM; OPTETRAK KNEE COMPONENTS

Catalog Number	02-012-44-1509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Implant Pain (4561)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s): catalog number, serial number, and exp date.
Event or Problem Description
Index surgery of optetrak knee components of the right knee in 2015.Revision due to pain in (b)(6) 2018.Female patient underwent revision and said that a ¿nuclear¿ analysis showed the implant was coming apart or debonding.
Additional Manufacturer Narrative
Section h10: (h3) the engineering evaluation noted in the revision reported was likely the result of aseptic (non-infected) loosening, which damaged the bond between the implant and the bone and likely contributed to the reported pain.However, this cannot be confirmed as the explants were not available for evaluation no information provided in the following section(s): a2, a4, a5, b6, b7, d4 (catalog number, serial number, and exp date), e3, g4, g5, and h4.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: a2.D4.D8.D10 concomitants: (b)(6) 02-010-01-0315 - logic femoral ps cem right sz 1.5.(b)(6) 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6) 200-02-29 - three peg patella 29mm.H6.E3.G1.G4.H4.The following sections were corrected: b1.B2.D1.D6b.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.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.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 9MM
• Common Device Name: OPTETRAK KNEE COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8754797
• Report Number: 1038671-2019-00342
• Device Sequence Number: 19371916
• Product Code: JWH
• UDI-Device Identifier: 10885862173430
• UDI-Public: 10885862173430
• Combination Product (Y/N): N
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2024

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: 02/04/2023
• Device Catalogue Number: 02-012-44-1509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 09/18/2019; 12/30/2024
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 10/16/2019; 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female