MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Erythema (1840); Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 11/25/2003

Event Type  Injury  

Event Description

It was reported that a patient enrolled in a clinical study underwent an initial left total hip arthroplasty on (b)(6) 2003 and an initial right hip arthroplasty on an unknown date.Subsequently, patient underwent an open reduction and internal fixation of the left hip on (b)(6) 2003 due to periprosthetic fracture caused by a fall.It is unknown what caused this fall.Patient underwent an incision and drainage with placement of antibiotic beads in the left hip on (b)(6) 2003 due to redness, swelling, pain, and periprosthetic femur fracture.It was further reported that patient underwent an incision and draining of the right hip with placement of antibiotic beads on (b)(6) 2003 due to a periprosthetic fracture caused by another fall.It is also unknown what caused this fall.An infection was found intraoperatively.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Product id - unknown; catalog number, lot number and expiration date - unknown; date implanted - unknown; 510k number - unknown; manufacture date ¿ unknown.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02178 / 02182).

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as the dictated report was marked incorrectly and there are no allegations for the right hip.

• Brand Name: UNKNOWN HIP
• Type of Device: PROSTHESIS, HIP
• 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: 4646138
• MDR Text Key: 5751857
• Report Number: 0001825034-2015-01278
• Device Sequence Number: 1
• Product Code: LPH
• 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: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 03/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 112