MAUDE Adverse Event Report: NOVOSOURCE, LLC NOVOHIP TOTAL HIP SYSTEM; HIP PROSTHESIS

Model Number 1125-0011

Device Problem Difficult to Insert (1316)

Patient Problem Hip Fracture (2349)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

Novosource will not take any remedial action as no inherit deficiency in the novohip system was identified.All catalog implants functioned as intended and do not introduce any unaccounted risk to the patient.Use and selection of novosource implant components are at the judgment of the surgeon regarding the patients anatomy, therefore no user error has been identified.

Event Description

It was reported that a patient's proximal femur fractured during a total hip arthoplasty.After following up with the reporter, it was discovered that the operation was a trauma case, meaning no pre-operative planning occurred.During the surgery, the surgeon determined that the desired leg length was not met with the initial selection of a size 9 stem.As a result, the surgeon elected to broach to a greater size stem.A size 11 novohip stem (pn: 1125-0011, ln: eur0034) was selected and a proximal femur fracture occurred.The surgeon repaired the patient's femur utilizing cables and implants from another system.

• Brand Name: NOVOHIP TOTAL HIP SYSTEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): NOVOSOURCE, LLC; 1000 hampton center; suite a; morgantown 26505
• Manufacturer (Section G): NOVOSOURCE LLC; 1000 hampton center; suite a; morgantown WV 26505
• Manufacturer Contact: melinda larkin ; 1000 hampton center; suite a; morgantown, WV 26505 ; 3045542167
• MDR Report Key: 18699552
• MDR Text Key: 335297791
• Report Number: 3014273644-2024-00001
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1125-0011
• Device Catalogue Number: 1125-0011
• Device Lot Number: EUR0034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male