MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-2509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Arthritis (1723); Fever (1858); Failure of Implant (1924); Pain (1994); Sepsis (2067); Syncope/Fainting (4411); Swelling/ Edema (4577)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post op the initial right tka, this 84 y/o female patient was revised due to the poly delaminating.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Product not returning - disposed.Photos attached.Unable to obtain x-rays.
Additional Manufacturer Narrative
Concomitant medical products: (h3) pending evaluation (d10) concomitant device(s): 5455309 02-010-03-0325 - logic cr femoral cem, right, sz 2.5 6295408 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t 6560535 200-02-35 - three peg patella 35mm 6560572 200-02-35 - three peg patella 35mm 6799765 201-78-15 - holding pin mini sharp point 4 pk 6743534 201-78-81 - 3 trocar, mod.Hex 2pk s103829 521-78-23 - threaded pin size 2.3 collared 5500935 521-78-32 - threaded pin size 3.0 collarless 12000220006 a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was performed due to polyethylene delamination per the experience report.However, the photographed device does not appear to show signs of prosthesis wear/delamination.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the device was not returned for evaluation.Section h11: the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
H10- additional information - b5.
Event or Problem Description
Additional information -"primary surgery: (b)(6) 2021 serial number: (b)(6) (02-012-51-2509) ¿ recall.Revision surgery: (b)(6) 2023 (procedure: right knee replacement + arthrotomy washout + liner exchange).Indications for the revision surgery are syncope and septic arthritis, after the revision surgery the patient must take antibiotics for several months.Clinical details: presented with fevers, knee pain, swelling, elevated crp and wcc.Aspirate on the ward had a turbid fluid and wcc.Removal of poly liner had some delamination possible cause of synovial reaction? pulsatile betadine/saline lavage with fluid as well to minimize biofilm.New 2.5 9mm crc poly insert." the cause of the suspected septic arthritis as related to the devices is unknown.The patient risk factors include age and having a joint prosthesis.No other information provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, g2 (australia), h6: clinical codes, types of investigation, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 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 ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 3523771140
• MDR Report Key: 16783912
• Report Number: 1038671-2023-00784
• Device Sequence Number: 12186201
• Product Code: JWH
• UDI-Device Identifier: 10885862230362
• UDI-Public: 10885862230362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/17/2026

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 Catalogue Number: 02-012-51-2509
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 12/19/2023; 03/10/2026
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/13/2023; 03/14/2024; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female