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

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK VARIO CUP PROSTHESIS FEMORAL HEAD BIPOLAR COMPONENT

  • 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
 

WALDEMAR LINK GMBH & CO. KG LINK VARIO CUP PROSTHESIS FEMORAL HEAD BIPOLAR COMPONENT Back to Search Results
Model Number 107-210/41
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 06/05/2020
Event Type  Injury  
Event Description
Dislocation of variocup prosthesis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLINK VARIO CUP PROSTHESIS
Type of DeviceFEMORAL HEAD BIPOLAR COMPONENT
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
annerike-tizia hucklenbroch
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key10199932
MDR Text Key196572040
Report Number3004371426-2020-00009
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K781735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number107-210/41
Device Catalogue Number107-210/41
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/26/2020 Patient Sequence Number: 1
-
-