MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year and 5 months post the initial total knee arthroplasty, the patient experienced a fall and injured his right knee.The patient underwent a bone scan which was reported to show increased uptake in the right patella region, thought to be due to possible loosening of the patella button, and hyperaemia at the right tibial tubercle in keeping with ligamentous insertional change and uptake was otherwise unremarkable in relation to the right knee prosthesis.The bone scan confirmed that the patient has subsequently developed component loosening.The surgeon recommended that the patient undergo a revision total knee replacement with cement fixation of the devices.The surgeon found a femur and patella hotspot on bone.The patient was revised to ps and the patella was changed.The femur had no on-growth.The patient's health was stable leaving the operating room.No additional information is available.
Additional Manufacturer Narrative
Report numbers: 1038671-2019-00278, 1038671-2024-03064.D10 concomitants: (b)(6), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t; (b)(6), 02-012-49-3011 - logic cr tib insert slope++, sz 3, 11mm; (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.E1: phone number (b)(6).The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2019-00278, 1038671-2024-03064 the revision reported may have been due to loosening and prosthesis wear.However, this cannot be confirmed and potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information 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 additional and/or corrected information.The following sections were corrected: d1: udi.The revision reported may have been due to loosening and prosthesis wear.However, this cannot be confirmed and potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information 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 3, 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 20895000
• Report Number: 1038671-2024-04744
• Device Sequence Number: 12955061
• Product Code: JWH
• UDI-Device Identifier: 10885862174420
• UDI-Public: 10885862174420
• 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: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 01/22/2023
• Device Catalogue Number: 02-012-49-3011
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 82 KG