• 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 PUSH-THROUGH STEM FOR TOTAL FEMUR REPLACEMENT CEMENTED - MEGASYSTEM-C DIAPHYSIS PROSTHESIS

  • 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 PUSH-THROUGH STEM FOR TOTAL FEMUR REPLACEMENT CEMENTED - MEGASYSTEM-C DIAPHYSIS PROSTHESIS Back to Search Results
Model Number 15-8523/76
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2017
Event Type  malfunction  
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 period, when the item was produced. The device was returned for investigation. The reported event is confirmed through investigation. There is no indication to suggest a material or manufacturing defect. The report is delayed due to inconsistencies with regard to foreign event reporting to fda. After re-evaluation of the complaint we determined that it is reportable. We have addressed the inconsistency in reporting foreign events to fda through capa (b)(4).
 
Event Description
It was reported that the sterile packaging is damaged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePUSH-THROUGH STEM FOR TOTAL FEMUR REPLACEMENT CEMENTED - MEGASYSTEM-C
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 Key8300957
MDR Text Key134873355
Report Number3004371426-2019-00080
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
Report Date 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model Number15-8523/76
Device Catalogue Number15-8523/76
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-