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

Model Number N/A

Device Problems Material Discolored (1170); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Hearing Impairment (1881); Hematoma (1884); Pain (1994); Paralysis (1997); Rash (2033); Visual Impairment (2138); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that a patient enrolled in a clinical study underwent a left total hip arthroplasty on (b)(6) 2003 and a right total hip arthroplasty in 1998.Subsequently, the patient underwent a left hip revision procedure on (b)(6) 2004 due to infection, loss of function, discoloration, rash, wound problems, limping, leg length discrepancy, knee/ankle problems, hematoma, lower extremity paralysis, pain and difficulty ambulating.Patient further noted fatigue, frequently feeling cold and hearing/vision changes.Patient underwent a revision procedure on the right hip in 2013 due to loss of function.

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.Date of event - unknown date in 2013.Product id - unknown; catalog number, lot number and expiration date - unknown; exact date implanted - unknown date in 1998; 510k number - unknown; manufacture date ¿ unknown.This report is number 1 of 8 mdrs filed for the same event (reference 1825034-2015-01350 & 01352 / 01358).

• 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: 4664766
• MDR Text Key: 15232374
• Report Number: 0001825034-2015-01350
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• 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: 03/11/2015
• 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 Weight: 77