MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG BIMOBILE

Model Number 184-101/46

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/04/2023

Event Type  Injury  

Event Description

Linkbio was notified by representative r.R.That the bimobile shell implanted on (b)(6) 2023 had an expiration date of feb.2023.The shell was then removed and replaced with a cluster-hole implant instead, with a changed out liner in order to convert.

• Brand Name: BIMOBILE
• Type of Device: BIMOBILE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16997157
• MDR Text Key: 315910827
• Report Number: 3006721341-2023-00011
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04026575174362
• UDI-Public: 04026575174362
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2023,05/24/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 184-101/46
• Device Catalogue Number: 184-101/46
• Device Lot Number: 180110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2023
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female