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

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Tissue Damage (2104); Osteolysis (2377); Reaction (2414)

Event Date 12/03/2003

Event Type  Injury  

Event Description

It was reported a patient enrolled in a clinical study underwent a right total hip arthroplasty on (b)(6) 2003 and a left total hip arthroplasty on (b)(6) 2004.Subsequently, patient underwent a right hip open reduction internal fixation procedure on (b)(6) 2003.Patient underwent a right hip revision procedure on (b)(6) 2003 due to an unknown reason.Patient underwent another right hip revision procedure on (b)(6), 2006 due to a fractured stem.Patient underwent another right hip revision procedure on (b)(6) 2007 due to a loosened acetabular cup.Patient underwent a left hip revision procedure on (b)(6) 2010 due to metallosis and bone/tissue damage.The modular head, acetabular cup and liner were removed and replaced with competitor cup and liner and a biomet head.

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.Expiration date - unknown, pma/510(k) number, manufacture date ¿ unknown.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2013-02668 & 04786 & 2014-02753-4).

• Brand Name: UNKNOWN MODULAR HEAD
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3752142
• MDR Text Key: 4414580
• Report Number: 0001825034-2014-02753
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• 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: 04/02/2014
• 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: 50 YR
• Patient Weight: 115