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

MAUDE Adverse Event Report: BIOMET UK LTD. IBP ELB INT. ULNA LRG RGT LNG STM 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 UK LTD. IBP ELB INT. ULNA LRG RGT LNG STM PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This user facility is outside of the united states. 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: date implanted - ni, this product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet manufactures a similar device in the united states under 510k number k043505. Remains implanted.
 
Event Description
Patient has been indicated for right elbow revision procedure due to loosening of the ulna component. No revision 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.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to not be reportable. Revision was indicated due to patient anatomy and the failure is not product or procedure related.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIBP ELB INT. ULNA LRG RGT LNG STM
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
daniel tilbury
waterton industrial estates
bridgend CF31 -3XA
UK   CF31 3XA
0441656655
MDR Report Key5748139
MDR Text Key48119833
Report Number3002806535-2016-00383
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Model NumberN/A
Device Catalogue Number114378
Device Lot Number2328723
Other Device ID NumberN/A
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 Received09/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2011
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: 06/24/2016 Patient Sequence Number: 1
-
-