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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM C STEM SEGMENT - CEMENTLESS DIAPHYSIS PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG MEGASYSTEM C STEM SEGMENT - CEMENTLESS DIAPHYSIS PROSTHESIS Back to Search Results
Model Number 15-8522/08
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Event Date 12/31/2018
Event Type  Injury  
Manufacturer Narrative
The review of the device history record showed no deviations. All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.
 
Event Description
It was reported that the stem segment fractured.
 
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Brand NameMEGASYSTEM C STEM SEGMENT - CEMENTLESS
Type of DeviceDIAPHYSIS PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
rebekka winterhoff
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key8338762
MDR Text Key136121128
Report Number3004371426-2019-00111
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Model Number15-8522/08
Device Catalogue Number15-8522/08
Device Lot Number1643170
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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: 02/14/2019 Patient Sequence Number: 1
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