MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG BIMOBILE DUAL MOBILITY SYSTEM; IMPACTOR HANDLE

Model Number 184-334/00

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

A small round ball has come loose from the release button, which meant that the bimobile cup that was already in situ could not be released.

• Brand Name: BIMOBILE DUAL MOBILITY SYSTEM
• Type of Device: IMPACTOR HANDLE
• 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: 18902656
• MDR Text Key: 337746191
• Report Number: 3004371426-2024-00026
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04026575439324
• UDI-Public: 04026575439324
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K211567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 184-334/00
• Device Catalogue Number: 184-334/00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1