MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN EXTREMITY; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 02/08/2016

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 sections could not be completed with the limited information provided.Expiration date - unknown; date implanted - unknown; initial reporter - unknown hospital; pma/510(k) number; manufacture date ¿ unknown.

Event Description

It was reported that patient underwent an elbow arthroplasty on an unknown date.Subsequently, a revision procedure has been indicated due to an unknown reason; however, no revision procedure has been reported to date.

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 an elbow arthroplasty on an unknown date.Subsequently, a revision procedure has been indicated due to radiographs revealing mechanical failure of device; however, no revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch and to relay corrected information.The following sections could not be completed with the limited information provided.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2015-03687 / 1825034-2016-04305).

Event Description

Patient underwent a right elbow revision procedure due to radiographs revealing mechanical failure of device.

Manufacturer Narrative

No product or photographs were returned, so condition of the device is unknown.Product history search cannot be completed since the lot number is unknown.This device is used for treatment.Part and lot identification are necessary for review of device history records and complaint history, and neither were provided.Without the opportunity to examine the complaint product, root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN EXTREMITY
• Type of Device: PROSTHESIS, ELBOW
• 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: 5009749
• MDR Text Key: 23224768
• Report Number: 0001825034-2015-03687
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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): Required Intervention
• Patient Age: 64 YR