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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG NECK SEGMENT WITHOUT COLLAR CEMENTLESS; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
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WALDEMAR LINK GMBH & CO. KG NECK SEGMENT WITHOUT COLLAR CEMENTLESS; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR Back to Search Results
Model Number 172-965/26
Device Problem Inaccurate Information (4051)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/09/2017
Event Type  malfunction  
Manufacturer Narrative
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 wrong neck segment was in the packaging.
 
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Brand Name
NECK SEGMENT WITHOUT COLLAR CEMENTLESS
Type of Device
PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
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 Key8296386
MDR Text Key134884247
Report Number3004371426-2019-00075
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model Number172-965/26
Device Catalogue Number172-965/26
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Initial Date Manufacturer Received 08/09/2017
Initial Date FDA Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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