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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK BIMOBILE INLAY BIMOBILE SYSTEM, INLAY, UHMWPE

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WALDEMAR LINK GMBH & CO. KG LINK BIMOBILE INLAY BIMOBILE SYSTEM, INLAY, UHMWPE Back to Search Results
Model Number 184-250/03
Device Problem Positioning Problem (3009)
Patient Problem Insufficient Information (4580)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
The review of the device history record showed no deviations. The product complies with the specifications valid at the time of manufacture.
 
Event Description
Prosthesis head could not be moved in the inlay of the cup. (translation).
 
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Brand NameLINK BIMOBILE INLAY
Type of DeviceBIMOBILE SYSTEM, INLAY, UHMWPE
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
annerike-tizia hucklenbroch
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key10711121
MDR Text Key212306635
Report Number3004371426-2020-00014
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K171273
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number184-250/03
Device Catalogue Number184-250/03
Device Lot Number2024227
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2020
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: 10/21/2020 Patient Sequence Number: 1
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