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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK ACTABULAR CUP; MOBILELINK ACETABULAR CUP SYSTEM
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WALDEMAR LINK GMBH & CO. KG MOBILELINK ACTABULAR CUP; MOBILELINK ACETABULAR CUP SYSTEM Back to Search Results
Model Number 183-101/52
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Joint Laxity (4526)
Type of Reportable Event Serious Injury
Event or Problem Description
Notified that a mobilelink cup implanted on (b)(6) 2025 by dr.(b)(6) is getting revised because the cup "spun out" but the screws are still connected.Revision will be done on the evening of (b)(6) 2026.Unknown event or event date.
 
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Brand Name
MOBILELINK ACTABULAR CUP
Common Device Name
MOBILELINK ACETABULAR CUP SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key24507763
Report Number3006721341-2026-00003
Device Sequence Number16056355
Product Code LPH
UDI-Device Identifier04026575175505
UDI-Public04026575175505
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/04/2026
Report Date (Section F) 02/10/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number183-101/52
Device Catalogue Number183-101/52
Device Lot Number231017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/09/2026
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer02/10/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/04/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age82 YR
Patient SexFemale
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