MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK ACETABULAR CUP SYSTEM; MOBILELINK ACETABULAR CUP SYSTEM, SHELL,MULTI HOLE, UNCEMENTED, TRABECULINK, O.D

Model Number	183-401/50
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The entire screw, including the head, slipped through the hole in the cup.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

• Brand Name: MOBILELINK ACETABULAR CUP SYSTEM
• Common Device Name: MOBILELINK ACETABULAR CUP SYSTEM, SHELL,MULTI HOLE, UNCEMENTED, TRABECULINK, 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: 25108420
• Report Number: 3004371426-2026-00034
• Device Sequence Number: 9326807
• Product Code: LPH
• UDI-Device Identifier: 04026575365166
• UDI-Public: 04026575365166
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K222066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 183-401/50
• Device Catalogue Number: 183-401/50
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 10/01/2025
• 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: 88 YR
• Patient Sex: Female