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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK EMBRACE; EMBRACE, GLENOSPHERE, COCRMO NEUTRAL, Ø 42 MM
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WALDEMAR LINK GMBH & CO. KG LINK EMBRACE; EMBRACE, GLENOSPHERE, COCRMO NEUTRAL, Ø 42 MM Back to Search Results
Model Number 646-042/00
Device Problem Positioning Failure (1158)
Patient Problem Insufficient Information (4580)
Event Date 11/11/2022
Event Type  malfunction  
Event Description
Fixation screw could not be screwed.
 
Event Description
Fixation screw could not be screwed.
 
Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
 
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Brand Name
LINK EMBRACE
Type of Device
EMBRACE, GLENOSPHERE, COCRMO NEUTRAL, Ø 42 MM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
Manufacturer Contact
lisa effe
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key15932018
MDR Text Key306065488
Report Number3004371426-2022-00047
Device Sequence Number1
Product Code PAO
UDI-Device Identifier04026575240777
UDI-Public04026575240777
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K200368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number646-042/00
Device Catalogue Number646-042/00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexMale
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