MAUDE Adverse Event Report: BIOMET ORTHOPEDICS THE ANSWER COCR HIP 9MMX125MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem Osteolysis (2377)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a total hip arthroplasty on (b)(6) 2001.Subsequently, the patient underwent revision procedure on (b)(6), 2014 due to loosening of the femoral stem and osteolysis behind the cup.All components were removed and replaced.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." and "material sensitivity reactions." this report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2014-07872 /-07873).

• Brand Name: THE ANSWER COCR HIP 9MMX125MM
• 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: 4119099
• MDR Text Key: 17629659
• Report Number: 0001825034-2014-07872
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK931194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2014

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 Expiration Date: 10/10/2010
• Device Model Number: N/A
• Device Catalogue Number: 162601
• Device Lot Number: 512460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2000
• 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): Life Threatening; Required Intervention
• Patient Age: 78 YR