MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 66 yo male patient, initial left knee implanted in (b)(6) 2018, underwent a revision procedure in (b)(6) 2023, approximately 5 years 1 month post the initial procedure.Revision of recalled devices indicated.All devices were removed.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-ray or imaging was available.The product is not returning for evaluation as it was discarded at the hospital.No device images were available.No further information.
Additional Manufacturer Narrative
D10: concomitants: a10012 - gps implant kit v2 (b)(6).02-010-03-0240 - logic cr femoral cem, left, sz 4 (b)(6).521-78-23 - threaded pin size 2.3 collared (b)(6).201-78-15 - holding pin mini sharp point 4 pk (b)(6).521-78-36 - threaded pin size 5.1 collarless (b)(6).02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t (b)(6).521-78-32 - threaded pin size 3.0 collarless (b)(6).200-00-00 - knee item-misc credit to logic.
Additional Manufacturer Narrative
Report number: 1038671-2024-04032 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: h6 the following sections were corrected: b2 d1 h3: device not returned.The revision reported may have been the result of prosthesis wear, as stated in the reported information.However, the prosthesis wear 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 returned for evaluation, and no relevant clinical information, radiographs, or images of the devices were 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 SLOPE+, SZ 4, 9MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20482329
• Report Number: 1038671-2024-04033
• Device Sequence Number: 4096115
• Product Code: JWH
• UDI-Device Identifier: 10885862174482
• UDI-Public: 10885862174482
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Catalogue Number: 02-012-48-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male