MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 5 years after initial left tka, the patient was revised due to wear on the patella and tibial insert.The patient was not revised to exactech devices.The event was not related to the breakage of a device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 02-010-04-0240 - logic cr femoral por, left, sz 4, (b)(6), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk, (b)(6), 521-78-23 - threaded pin size 2.3 collared, (b)(6), 521-78-23 - threaded pin size 2.3 collared, (b)(6), 521-78-32 - threaded pin size 3.0 collarless, (b)(6), a10012 - gps implant kit v2.
Additional Manufacturer Narrative
(h3) the reason for the revision reported may have been due to wear of the tibial insert and patella component, as stated in the experience report.However, the reported event could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 19739968
• Report Number: 1038671-2024-02383
• Device Sequence Number: 3616411
• Product Code: JWH
• UDI-Device Identifier: 10885862174499
• UDI-Public: 10885862174499
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 03/09/2023
• Device Catalogue Number: 02-012-48-4011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male