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

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem Unspecified Infection (1930)

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported that patient underwent right total hip arthroplasty on an unknown date.Subsequently, patient was revised on an unknown date with spacer molds due to infection.A re-implantation procedure took place on (b)(6) 2014.During the procedure, there was difficulty in locking the screw between the cone and distal body components.The surgeon left the screw in although it could not be tightened.

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.Event is being reported to fda on one medwatch as the limited information available indicates that a revision has occurred.Should additional information be received, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Manufacturer Narrative

This medwatch was filed in error.Additional information received indicates no biomet product was involved in this issue.This medwatch is being considered void at this time.

• 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: 4375590
• MDR Text Key: 5119500
• Report Number: 0001825034-2014-09315
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

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
• 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: 01/19/2015
• Initial Date FDA Received: 12/31/2014
• 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: 82 YR
• Patient Weight: 79