• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISCOVERY ELBOW SYSTEM EXTRA SMALL FLANGED HUMERAL LEFT PROSTHESIS, ELBOW

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS DISCOVERY ELBOW SYSTEM EXTRA SMALL FLANGED HUMERAL LEFT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Detachment Of Device Component (1104)
Patient Problem Reaction (2414)
Event Date 04/19/2017
Event Type  Injury  
Manufacturer Narrative
Reported event was unable to be confirmed. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined. 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.
 
Manufacturer Narrative
(b)(4). Concomitant medical product-disc xs condyle kit w align, catalog#: 114991, lot#: 665670. Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03356.
 
Event Description
It is reported that the patient underwent a total elbow arthroplasty revision approximately ten (10) months post-implantation due to screw loosening with onset approximately seven to eight (7-8) months post-operatively. During the revision, the surgeon noted metallosis inside the joint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDISCOVERY ELBOW SYSTEM EXTRA SMALL FLANGED HUMERAL LEFT
Type of DevicePROSTHESIS, 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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6578083
MDR Text Key134210585
Report Number0001825034-2017-03357
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
PK090473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number114912
Device Lot Number510780
Other Device ID NumberREFERENCE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/19/2017 Patient Sequence Number: 1
-
-