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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Itching Sensation (1943); Swelling (2091)

Event Date 04/22/2013

Event Type  Injury  

Event Description

It was reported that the patient had a right hip arthroplasty on (b)(6) 2010 and a left hip arthroplasty on an unknown date in 2012.Subsequently, the patient was revised on the left hip on (b)(6) 2013 due to swelling and slight movement with implants.The patient is now experiencing swelling, bruising, itching and redness on the right hip and will have allergy testing performed on an unknown date.There is no reported revision for the right hip.

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.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2014-09196 / 09197).

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that the patient underwent a right total hip arthroplasty on an unknown date and a left total hip arthroplasty in 2012.Subsequently, the patient was revised on the right side on (b)(6) 2010 due to unknown reasons.Patient underwent a left hip revision procedure on (b)(6) 2013 due to swelling and slight movement with implants.Patient is now experiencing swelling, bruising, itching and redness on the right hip and will have allergy testing performed on an unknown date.There is no reported revision for the right hip.

• Brand Name: UNKNOWN
• 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: 4343550
• MDR Text Key: 5139437
• Report Number: 0001825034-2014-09197
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNK
• 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,Followup
• Report Date: 03/06/2015

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: UNK HIP
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2015
• 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