MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK ACETABULAR CUP SYSTEM; SHELL, CLUSTER HOLE, UNCEMENTED, TICAP, O.D.= 46MM, FOR INSERT SIZE B, TILASTAN-

Model Number	183-101/46
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During total hip replacement surgery, one screw of the 46mm mobilelink acetabular cup could not be removed, resulting in a modified surgical procedure.[customer].
Additional Manufacturer Narrative
The review of the quality data analysis (qda data) showed no deviations.This is the final supplemental report, the complaint is closed.
Event or Problem Description
During total hip replacement surgery, one screw of the 46mm mobilelink acetabular cup could not be removed, resulting in a modified surgical procedure.

• Brand Name: MOBILELINK ACETABULAR CUP SYSTEM
• Common Device Name: SHELL, CLUSTER HOLE, UNCEMENTED, TICAP, O.D.= 46MM, FOR INSERT SIZE B, TILASTAN-
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19989992
• Report Number: 3004371426-2024-00055
• Device Sequence Number: 20597390
• Product Code: LPH
• UDI-Device Identifier: 04026575175475
• UDI-Public: 04026575175475
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K182321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 183-101/46
• Device Catalogue Number: 183-101/46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female