MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK ACETABULAR CUP SYSTEM; SHELL/INSERT ADAPTER FOR SHELL 74-80 MM, INSERT SIZE F, + 12 MM OFFSET

Model Number	183-610/05
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was checked and the offset of the label does not confirm to the specification.It has come to our attention that the offset on the labels of the shell/insert adapter does not match to the article ref and the description in the surgical technique.This only affects the article ref 183-610/05.For these products it should be +12 mm offset on all labels including the label for the implant card, but the shell/insert adapter were incorrectly labelled as + 8 mm offset.The product in the packaging has a +12 mm offset, which is correct and fits to the article ref and the description of the surgical technique.Waldemar link gmbh & co.Kg is therefore providing a safety information and recalling the affected items from the market: r-2023-08.
Event or Problem Description
Please see attached complaint re labelling issue with mobilelink liner 183-610/05, also below image shows the label states +8mm rather than +12mm as should be.The representative noticed the discrepancy in the labeling when checking customer's inventory.[customer].

• Brand Name: MOBILELINK ACETABULAR CUP SYSTEM
• Common Device Name: SHELL/INSERT ADAPTER FOR SHELL 74-80 MM, INSERT SIZE F, + 12 MM OFFSET
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17335124
• Report Number: 3004371426-2023-00059
• Device Sequence Number: 6477614
• Product Code: OQG
• UDI-Device Identifier: 04026575182329
• UDI-Public: 04026575182329
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Relabeling
• Type of Report: Initial
• Report Date (Section B): 07/04/2023

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 Expiration Date: 06/20/2026
• Device Model Number: 183-610/05
• Device Catalogue Number: 183-610/05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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