MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3511
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op the initial left tka, this 70 y/o male patient was revised.Surgeon preformed a poly swap due to recall poly, poly wear, osteolysis.
Additional Manufacturer Narrative
Concomitant device(s): 4788326 02-010-03-0235 - logic cr femoral cem, left, sz 3.5, 5813622 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t, 5771910 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
Section h10: (h3) the most likely cause for the revision is prosthesis wear as reported.A contributing factor to the extent of wear on the returned device may be the result of being packaged in a non-conforming bag for more than 5 years.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, d9.The following sections were corrected: b2, g1, g2, h6 clinical code.
Event or Problem Description
The poly was broken into pieces posteriorly - the poly and its visible pieces were removed and the knee was irrigated.There was a 15 - 30 minute surgical delay/prolongation.Patient did not experience any adverse events as a result of delay/prolongation.The patient had to undergo revision knee surgery and had to wait to obtain another poly for insertion due to wrong initial insertion and locking.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d.The most likely cause for the revision is prosthesis wear as reported.A contributing factor to the extent of wear on the returned device may be the result of being packaged in a non-conforming bag for more than 5 years.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 3.5, 11 MM
• 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: geoff gannon ; 3523771140
• MDR Report Key: 16333664
• Report Number: 1038671-2023-00126
• Device Sequence Number: 6332537
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2025

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: 03/06/2021
• Device Catalogue Number: 02-012-49-3511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 02/20/2025; 07/11/2025
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 12/29/2023; 03/11/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2013
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG