MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG BIMOBILE DUAL MOBILITY SYSTEM; LINER, X-LINKED VIT-E PE, I.D.= 28MM, FOR SHELL O.D. 70 MM

Model Number	184-280/12
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A data research of the labels had been conducted.Product recall r-2024-01 is initiated.
Event or Problem Description
Labeling "f instead of g".
Additional Manufacturer Narrative
A data research of the labels had been conducted.The product recall r-2024-01 is being finalized.
Event or Problem Description
Labeling "f instead of g".

• Brand Name: BIMOBILE DUAL MOBILITY SYSTEM
• Common Device Name: LINER, X-LINKED VIT-E PE, I.D.= 28MM, FOR SHELL O.D. 70 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 18570366
• Report Number: 3004371426-2024-00012
• Device Sequence Number: 8203830
• Product Code: MEH
• UDI-Device Identifier: 04026575230747
• UDI-Public: 04026575230747
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K190535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 184-280/12
• Device Catalogue Number: 184-280/12
• Device Lot Number: 2325426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: Unknown