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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK® ENDO-MODEL® SLED PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG LINK® ENDO-MODEL® SLED PROSTHESIS Back to Search Results
Model Number 15-2220/52
Device Problems Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)
Patient Problem Failure of Implant (1924)
Event Date 09/13/2018
Event Type  Injury  
Manufacturer Narrative
After reevaluation of the event information we determined the event is reportable.
 
Event Description
It was reported a aseptic loosening.
 
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Brand NameLINK® ENDO-MODEL® SLED PROSTHESIS
Type of DeviceLINK® ENDO-MODEL® SLED PROSTHESIS
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, 22339
GM 22339
Manufacturer Contact
omid rahmatian
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key8212099
MDR Text Key131908637
Report Number3004371426-2019-00001
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K152431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2018
Device Model Number15-2220/52
Device Catalogue Number15-2220/52
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
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: 01/03/2019 Patient Sequence Number: 1
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