MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN JUGGERKNOT; FASTENER, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Rash (2033)

Event Date 03/01/2013

Event Type  Injury  

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.The following could not be completed with the limited information provided.Device product code - ni, expiration date - ni, manufacture date ¿ ni.

Event Description

Patient alleged developing a systematic rash due to a possible metal allergy three years post implantation.No revision has been reported.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as patient is alleging metal allergies and the zimmer biomet product implanted does not contain metal.

• Brand Name: UNKNOWN JUGGERKNOT
• Type of Device: FASTENER, FIXATION
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6130122
• MDR Text Key: 60965641
• Report Number: 0001825034-2016-04887
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2016
• 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