MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET HIP FRACTURE FMRL 10MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Type  Injury  

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 or deviation.Remains implanted.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and allergic reaction.¿ this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2015-04935 / 04936 / 04937).

Event Description

It was reported that patient underwent left total hip arthroplasty on (b)(6) 2006.Subsequently, patient is experiencing a reoccurring rash due to unknown causes.A metal allergy test is scheduled to occur.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent left total hip arthroplasty on (b)(6) 2006.Subsequently, patient is experiencing a reoccurring rash due to unknown causes.A metal allergy test is scheduled to occur.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Additional information received reported the rash was confirmed as an allergic reaction; however, it is unknown if it a metal allergy.No revision procedure will be performed.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: BIOMET HIP FRACTURE FMRL 10MM
• 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: 5277564
• MDR Text Key: 33038146
• Report Number: 0001825034-2015-04937
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 162901
• Device Lot Number: 314620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2006
• 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): Other