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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Event details and product identification were not provided for the patient mentioned in the journal article.Product location unknown.

Event Description

Information was received based on review of a journal article titled, ¿comparison of whole-blood metal ion levels among four types of large-head, metal-on-metal total hip arthroplasty implants.¿ this was a follow-up to a study which aimed to: to compare chromium, cobalt, and titanium ion concentrations in the whole blood of patients who received any of four types of total hip arthroplasty implants with a large-diameter femoral head; to assess the progression of ion levels over time; and to identify factors influencing metal ion concentrations.A patient identified in the article experienced elevated metal ion levels.No revision procedure has been reported to date and the patient's outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to correct information.

• Brand Name: UNKNOWN MAGNUM 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: 5846335
• MDR Text Key: 51139667
• Report Number: 0001825034-2016-02881
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• 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): Other