MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIO-MOD HUM HEAD 44DIAX22MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Toxicity (2333)

Event Type  Injury  

Event Description

Patient reported to have undergone left shoulder arthroplasty on an unknown date in (b)(6) 2003.Subsequently, patient reported allegations of high nickel ions levels.No revision has been reported to date.

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions.".

Manufacturer Narrative

Corrected data: initial surgery was confirmed to have taken place on (b)(6) 2003.Date implanted - (b)(6) 2003.

Event Description

Patient reported to have undergone left shoulder arthroplasty on an unknown date in (b)(6) 2003.Patient further reports allegations of high nickel ions levels.No revision has been reported to date.A review of invoice history revealed that the initial shoulder arthroplasty took place on (b)(6) 2003.

• Brand Name: BIO-MOD HUM HEAD 44DIAX22MM
• 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: 4552291
• MDR Text Key: 16628918
• Report Number: 0001825034-2015-00720
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 113766
• Device Lot Number: 616600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2003
• 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