MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-47-5009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2022.The patient presented to the surgeon with complaints of pain, swelling, instability and dissatisfaction with their left tka.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs.A complete revision.The patient was revised on (b)(6) 2023.The poly and patella implants were exchanged.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: optetrak 3 peg patella cemented 32mm 200-02-32 3738869.Or optetrak 3 peg patella cemented 35mm 200-02-35 3711834.Unknown which is left or right.H7: z-0021-2022.
Additional Manufacturer Narrative
Correction: dates entered in error on initial report in f6 and f9, contact person in g, h6 clinical code, h6 problem code, h6 component code.Additional information: h6 type of investigation, h6 investigation findings, h6 investigation conclusions, d10 concomitant devices.D10: (b)(6), 02-010-03-0250 - logic cr femoral cem, left, sz 5.(b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e.The revision reported cannot be determined from the information provided but may be the result of prosthesis wear, instability or inclusion of the polyethylene in the packaging recall.The articular surfaces of the tibial insert and patella appear unremarkable in regards to wear.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information 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 CR TIB INSERT STD, SZ 5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17094837
• Report Number: 1038671-2023-01298
• Device Sequence Number: 1868564
• Product Code: JWH
• UDI-Device Identifier: 10885862174543
• UDI-Public: 10885862174543
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 01/31/2020
• Device Model Number: 02-012-47-5009
• Device Catalogue Number: 02-012-47-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 11/04/2024; 01/30/2025
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 11/06/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG