MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: - logic pts, size 4, 8mm (cat# 02-012-42-4008 / serial# (b)(6).- trapezoid tibial tray sz 4f/4t (cat# 204-04-44 / serial# (b)(6).- fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6).- tibial augment block 1/2-sz 4 5mm (cat# 204-64-05 / serial# (b)(6).- tibial augment block 1/2-sz 4 5mm (cat# 204-64-05 / serial# (b)(6).- tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the male patient had original right revision knee performed on (b)(6) 2018.The patient presented back to surgeon's office with complaints of their bilateral tka's.Upon examination poly wear and osteolysis is evident.The poly implant within the patient is involved in the recall.The patient was scheduled for a revision right tka possible poly swap on (b)(6) 2023.The patient underwent a full knee revision to competitor's products.The exactech poly showed early wear and the metal implants were loose on the bone.There was no breakage of device.There was a greater than 45 minutes surgical delay but there was no adverse events as a result.Photos and images received.The device are not available for evaluation because the implants are sent to the hospital lab and then legal.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported may be the result of prosthesis wear, femoral loosening, and tibial loosening, or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component and the tibial construct to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.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 TIB INSERT IMPL CRC, SZ 4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17733427
• Report Number: 1038671-2023-02248
• Device Sequence Number: 15063036
• Product Code: JWH
• UDI-Device Identifier: 10885862230492
• UDI-Public: 10885862230492
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 04/16/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM
• Device Catalogue Number: 02-012-51-4011
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2013
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male