MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN INTRAMEDULLARY NAIL; NAIL, FIXATION BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "the management of pediatric subtrochanteric femur fractures with a statically locked intramedullary nail" which aimed to evaluate locked intramedullary fixation as an alternative treatment method for children with subtrochanteric fractures using the statically locked lateral entry intramedullary nail (pediatric locked nail) manufactured at biomet warsaw.The study consisted of 9 males and 1 female patient with an average age of 12 years and average follow-up of 22 months.Most of the fractures occurred secondary to high-energy trauma.Implants were removed on average of 11 months post implantation.There were no intraoperative complications recorded nor major complications in the postoperative period after removal.Two patients presented with a longer limb on the affected side, and two presented with asymptomatic grade i heterotopic ossification.All of which did not require treatment and were linked to the initial trauma, and not the implant.In conclusion, the use of the statically locked laterally entry im nail for subtrochanteric femur fractures in children is a safe and efficacious method of treatment with few complications and risks, and satisfactory outcomes in children over the age of eight.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Date of event - unknown.Catalog number, lot number and expiration date - unknown.Date implanted - unknown.Initial reporter -the article was written by herrera-soto, j.Et al; journal of orthopaedic trauma publish ahead of print: doi: 10.1097/bot.0000000000000156.Manufacture date ¿ unknown.It is likely that these complications have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

• Brand Name: UNKNOWN INTRAMEDULLARY NAIL
• Type of Device: NAIL, FIXATION BONE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4463505
• MDR Text Key: 5188237
• Report Number: 0001825034-2015-00379
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention