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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

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WALDEMAR LINK GMBH & CO. KG LINK VARIO CUP PROSTHESIS FEMORAL HEAD BIPOLAR COMPONENT Back to Search Results
Model Number 107-210/42
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 05/05/2020
Event Type  Injury  
Manufacturer Narrative
The review of the device history record showed no deviations. All product features correspond with the valid specifications of the waldemar link gmbh & co. Kg at the time, when the product was produced.
 
Event Description
Dislocation of variocup prosthesis.
 
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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 (Section G)
WALDEMAR LINK GMBH & CO KG
barkhausenweg 10
hamburg,
GM
Manufacturer Contact
annerike-tizia hucklenbroch
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key10117717
MDR Text Key193954836
Report Number3004371426-2020-00006
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K781735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number107-210/42
Device Catalogue Number107-210/42
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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: 06/04/2020 Patient Sequence Number: 1
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