MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 5, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-5017
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6).02-012-50-5013 - tru tib aug 1/2 rm sz 5, 10mm.(b)(6).02-012-61-6000 - tru offset stem ext coupler, 6mm.(b)(6).02-012-61-6000 - tru offset stem ext coupler, 6mm.(b)(6).02-012-64-1480 - tru fluted stm ext 14mm x 80mm blast.(b)(6).02-010-06-0551 - tru post.Aug.Size 5, 5mm.(b)(6).208-05-05 - cc distal fem augment sz 5, 5mm.(b)(6).02-010-06-0350 - tru cc femoral size 5 right.(b)(6).208-05-05 - cc distal fem augment sz 5, 5mm.(b)(6).201-78-25 - small headed sharp pin, 1 1/8" 4 pack.(b)(6).208-06-05 - cc distal fem augment sz 5, 10mm.(b)(6).02-012-64-1612 - tru fluted stm ext 16mm x120mm blast.(b)(6).208-10-15 - cc femoral aug screw 15mm.(b)(6).02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.(b)(6).200-07-35 - advanced patella 35mm 3 peg implant.(b)(6).521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(6).521-78-32 - threaded pin size 3.0 collarless 2pk.(b)(6).521-78-23 - threaded pin size 2.3 collared 2pk.
Event or Problem Description
It was reported that this 71 y/o male patient received knee implant following a spacer removal on (b)(6) 2023.Surgeon wanted to check and make sure the wound wasn't draining into the capsule and wanted to wash it out.Surgeon then decided to swap out the 5 x 17mm cc poly for a new one.Patient was last known to be in stable condition following the event.No images or x-rays available.Devices are not returning - hospital doesn't release.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported revision cannot be confirmed from the information provided but may be due to wear, loosening, infection, fracture, instability, and/or patient related factors.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information, images, or 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 CC TIB INSERT SIZE 5, 17MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18181572
• Report Number: 1038671-2023-02828
• Device Sequence Number: 7611419
• Product Code: JWH
• UDI-Device Identifier: 10885862266262
• UDI-Public: 10885862266262
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Catalogue Number: 02-012-65-5017
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 71 YR
• Patient Sex: Male