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

Model Number	02-012-48-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op the initial tka, this male patient showed up to clinic with pain and recurrent effusions.Surgeon noted moderate poly wear and oxidation upon examining the insert.He also stated there was no significant osteolysis on imaging.New 11crc insert was implanted with good rom and stability.Patient left in stable condition.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 02-010-03-0340, 4948624, logic cr femoral cem, right, sz 4.02-012-45-4040, 4949766, lgc tibial fit tray cem sz 4f / 4t.200-02-38, 4802134, three peg patella 38mm.204-34-02, 4906993, fluted stem extension 25l x 14 mm.204-70-00, 4934190, tibial stem ext.Screw.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of mechanical overload on the posterior medial edge of the tibial insert.Contributions from the posterior slope, rotational alignment and/or potential ligamentous/soft tissue imbalances to the sequence of events cannot be determined from the reported clinical information and the device was not available for evaluation.Additionally, a contributing factor to the severity of the wear and delamination may have been result of being packaged in a non-conforming vacuum bag for more than five 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 corrected information.The following sections were corrected: b1, b2, d8, g1, h6: clinical code, investigation findings, investigation conclusions.The revision reported was likely the result of mechanical overload on the posterior medial edge of the tibial insert.Contributions from the posterior slope, rotational alignment and/or potential ligamentous/soft tissue imbalances to the sequence of events cannot be determined from the reported clinical information and the device was not available for evaluation.Additionally, a contributing factor to the severity of the wear and delamination may have been result of being packaged in a non-conforming vacuum bag for more than five 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 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15240512
• Report Number: 1038671-2022-00922
• Device Sequence Number: 6293519
• Product Code: JWH
• UDI-Device Identifier: 10885862174499
• UDI-Public: 10885862174499
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 02/27/2020
• Device Model Number: 02-012-48-4011
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 12/19/2022; 02/06/2026
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 01/04/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male