MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +. SZ 3.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.5 years post op initial right tka, this female patient was revised due to severe poly wear.Revised from cr to ps.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain x-rays.Product not returning / disposed at hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6) 02-010-04-0335 - logic cr femoral por, right, sz 3.5.(b)(6) 02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t.(b)(6) 200-02-38 - three peg patella 38mm.(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
Section h10: (h3) the revision reported is most likely the result of prosthesis wear secondary to instability of the knee joint.However, this cannot be confirmed as the devices were not returned for evaluation and limited clinical information was provided.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 corrected information.The following sections were corrected: b1, b2, b3, d6b, d8, h6: clinical code, type of investigation, investigation findings, investigation conclusions 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, 9 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 17266001
• Report Number: 1038671-2023-01561
• Device Sequence Number: 5911468
• Product Code: JWH
• UDI-Device Identifier: 10885862159281
• UDI-Public: 10885862159281
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Catalogue Number: 02-012-48-3509
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 12/12/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/11/2023; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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
• 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: Hospitalization; Required Intervention
• Patient Sex: Female