MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ELBOW SYSTEMS : DISCOVERY ELBOW SYSTEM; PROSTHESIS - ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The product was not available for return.Root cause could not be determined.Conditions are addressed in the package insert.Due to a lack of part and lot numbers, manufacturing, deviation and complaint histories were unable to be located and assessed.Sterilization certificates were also unable to be located and assessed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

Event Description

Information was received based on review of a journal article titled, "medium-term clinical results of a linked total elbow replacement system¿ which examined a large series of discovery primary ters with analysis of indications, objective outcomes, radiography, complications and revision data.The study followed forty-eight (48) patients who received fifty-one (51) consecutive primary discovery total elbow replacements between april 2008 and november 2011.It was reported that one (1) patient has developed ulnar neuritis and complex regional pain syndrome.There has been no further information provided and the patient outcome is unknown.

• Brand Name: ELBOW SYSTEMS : DISCOVERY ELBOW SYSTEM
• Type of Device: PROSTHESIS - ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6933767
• MDR Text Key: 89174697
• Report Number: 0001825034-2017-08295
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK DISCOVERY ELBOW
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2014
• 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