MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2009
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 4768501 - 02-010-03-0320 - logic cr femoral cem, right, sz 2, 5394950 - 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t, 11041017140 - a10012 - gps disposable kit.
Event or Problem Description
It was reported that this male patient right knee was revised.About 6 years later from a primary surgery, the patient who had total knee arthroplasty using cr slope ++ tibial insert complained knee swelling and pain, the surgeon diagnosed the wear of the tibial insert, then revision surgery for the replacement of the tibial insert was performed.Breakage and wear was observed in the retrieved tibial insert.Also, he did not found out metallosis.He decided that no problem of locking mechanism of the tibial tray was found, and removing all proliferative tissues, the insert only was replaced to new crc one with 9mm.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Product not returning - a retrieved insert would be used for clarification to a patient.
Additional Manufacturer Narrative
H3: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, was likely the result of prosthesis wear and fracture which may have been due to a combination of axial rotation mismatch between the tibial and femoral components, excessive combined posterior tibial slope and changes in soft tissue function since the initial surgery.A contributing factor to the wear on the tibial insert may have been due to the revised tibial insert having been packaged in a non-conforming bag for five years.However, this cannot be confirmed as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d6b.The following sections were corrected: b2, h6.The revision reported was likely the result of prosthesis wear and fracture which may have been due to a combination of axial rotation mismatch between the tibial and femoral components, excessive combined posterior tibial slope and changes in soft tissue function since the initial surgery.A contributing factor to the wear on the tibial insert may have been due to the revised tibial insert having been packaged in a non-conforming bag for five years.However, this cannot be confirmed as the devices were not returned for evaluation.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 2, 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19571137
• Report Number: 1038671-2024-02025
• Device Sequence Number: 11754701
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 01/23/2025

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: 03/09/2020
• Device Catalogue Number: 02-012-49-2009
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 12/06/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 12/23/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male