MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 4 13MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical device: concomitant device: logic tibia ps mod insrt sz 4 13mm, cat# 02-012-35-4013 / serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient who received a bilateral tkr on (b)(6) 2017 returned complaining of pain in the right knee.The tibial component appeared to show signs of loosening.The patient was scheduled for a tibial revision.The revision was performed on (b)(6) 2021.The tibial tray and insert were removed.There was bone loss in the tibia, so a cone and tibial augments were implanted.Patient was last known to be in stable condition following the event.The device will not be returned due to hospital retains all retrievals.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the tibial tray and the bone and patient-related conditions, which led to aseptic (non-infected) tibial loosening.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of "loosening - tibial" is associated with weakened integration of the tibial component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12392262
• Report Number: 1038671-2021-00456
• Device Sequence Number: 14610941
• Product Code: JWH
• UDI-Device Identifier: 10885862003232
• UDI-Public: 10885862003232
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: 10/30/2021
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• Device Catalogue Number: 02-012-35-4013
• 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: 08/11/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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: Disability; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 88 KG