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 Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Scar Tissue (2060); Discomfort (2330); Ambulation or Postural Difficulties (2544); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 73 y/o female patient's left knee was revised due to wear.The original implanted cr poly insert showed signs of wear on x-ray.The affected poly was removed and revised to a crc size 2, 9mm component.Patient was last known to be in stable condition following the event.Devices are not returning, unable to obtain from facility.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6) 200-02-32 - three peg patella 32mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.4046821 02-010-03-0220 - logic cr femoral cem, left sz 2.4085570 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6 the following sections were corrected: g3, h6 mdr section codes updated/corrected: b, c, d, e, g the reason for the revision reported cannot be confirmed from the information provided, but may be the result of prosthesis wear, and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.The reason for the revision reported cannot be confirmed from the information provided, but may be the result of prosthesis wear, and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6; health effect - clinical code.
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: b, e the reason for the revision reported cannot be confirmed from the information provided, but may be the result of prosthesis wear, and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19274836
• Report Number: 1038671-2024-01142
• Device Sequence Number: 20745478
• Product Code: JWH
• UDI-Device Identifier: 10885862174314
• UDI-Public: 10885862174314
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 06/17/2019
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 12/12/2024; 02/19/2025; 03/25/2025
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 12/16/2024; 12/18/2024; 03/12/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2011
• 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: Required Intervention
• Patient Sex: Female