MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MobileLink Acetabular Cup System; MobileLink Acetabular Cup System, Shell, Cluster Hole, uncemented, TiCaP, O.D.=

Model Number	183-101/52
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2025
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." "[customer]".

• Brand Name: MobileLink Acetabular Cup System
• Common Device Name: MobileLink Acetabular Cup System, Shell, Cluster Hole, uncemented, TiCaP, O.D.=
• 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 Key: 24542621
• Report Number: 3004371426-2026-00021
• Device Sequence Number: 18512916
• Product Code: LPH
• UDI-Device Identifier: 04026575175505
• UDI-Public: 04026575175505
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K182321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Model Number: 183-101/52
• Device Catalogue Number: 183-101/52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female