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

Model Number	184-101/46
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Use of an expired product.
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product and all labels comply with the specifications valid at the time of manufacture.
Event or Problem Description
Distributor was notified by representative 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 mobile link cluster-hole implant instead, with a changed out liner in order to convert.[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: BIMOBILE DUAL MOBILITY SYSTEM
• Common Device Name: TICAP SHELL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16973162
• Report Number: 3004371426-2023-00024
• Device Sequence Number: 14089127
• Product Code: MEH
• UDI-Device Identifier: 04026575174362
• UDI-Public: 04026575174362
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 184-101/46
• Device Catalogue Number: 184-101/46
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2018
• 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: Other
• Patient Sex: Unknown