MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ALPS ELBOW OLECRANON PLATE; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

It was reported by a surgeon that the alps elbow olecranon plate is not fitting correctly.The proximal holes are not purchasing enough bone.This issue potentially increases the possibility of adverse events, revisions, or delays in procedures as a result of using this device.

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.Investigation into this issue is ongoing and if additional information is received, a follow-up report will be submitted.The following sections could not be completed with the limited information provided.Date of event - unknown.Brand name - unknown.Catalog number, lot number and expiration date - unknown.Date implanted - unknown.510k number - unknown.Manufacture date ¿ unknown.

Manufacturer Narrative

This follow-up report is to correct information that was reported on a previous medwatch.Report has been reassessed as a product problem and not a serious injury as there were no adverse outcomes as a result of this event.

• Brand Name: ALPS ELBOW OLECRANON PLATE
• 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: 4178016
• MDR Text Key: 5157808
• Report Number: 0001825034-2014-08161
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNK OLECRANON PLATE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2015
• 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): Hospitalization; Required Intervention