MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number LOGIC TIBIA PS MOD INSRT TRIAL SZ 2.5 9MM

Device Problem Material Fragmentation (1261)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 62 yo female patient, initial left knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 3 years 9 months post the initial procedure due to complaints of stiffness in their knee.During the procedure, the trial logic poly was removed using the logic style poly handle and once removed it was shown that the poly trial had broken on the underside.The surgeon used a rongure to remove the broken poly trial piece from the tibial tray and wound.The knee joint and surrounding wound was irrigated well.The new 9mm ps poly implant for the sz 2.5 was implanted into the knee and a final rom was performed.The surgeon was satisfied.There was a surgical delay while removing the parts and pieces from the wound site with no adverse event to the patient.The patient left the or stable.The device is available for return.The revision procedure is reported under report #1038671-2022-01327.

Manufacturer Narrative

After review of additional information received the following sections, have been updated accordingly: h6: based on historical complaint investigations, the returned device, and the reported event, the fractured logic ps tibial insert trial reported may have been the result of years of surgical use, aggressive use, and subsequent sterilization cycles which led to crack initiation, propagation, and ultimate fracture of the device during trialing.

• Brand Name: LOGIC
• Type of Device: 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: 15629245
• MDR Text Key: 301979695
• Report Number: 1038671-2022-01328
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862004215
• UDI-Public: 10885862004215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: LOGIC TIBIA PS MOD INSRT TRIAL SZ 2.5 9MM
• Device Catalogue Number: 02-013-35-2509
• Device Lot Number: 12160792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female