MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MOBILELINK; MOBILELINK ACETABULAR CUP SYSTEM, INSERT, X-LINKED VIT-E PE, I.D.= 32MM, INSERT

Model Number	183-371/32
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
"notified by (b)(6) on (b)(6) 2025, that 2 mobilelink inserts would not seat onto the shell during a procedure.There was approximately a 20 minute delay in the procedure.The 48 mm shell (183-101/48) was implanted with 2 screws in place, but the liner would not seat correctly.There was no evidence of the screws being proud.The screws were removed and the liner still did not seat.An additional liner was opened but it also did not seat correctly.Then the shell was instead changed to a trabeculink shell (183-201/48) but neither of the 2 liners still did not seat.A 183-361/32 liner was finally used and it seated correctly.The parts implanted were 183-201/48, lot: 220302/0848 with 183-361/32, lot: 2323127.The shell and both inserts are being shipped for the investigation." [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.This is the final supplemental report, the complaint is closed.
Event or Problem Description
"notified by (b)(6) on (b)(6) 2025, that 2 mobilelink inserts would not seat onto the shell during a procedure.There was approximately a 20 minute delay in the procedure.The 48 mm shell (183-101/48) was implanted with 2 screws in place, but the liner would not seat correctly.There was no evidence of the screws being proud.The screws were removed and the liner still did not seat.An additional liner was opened but it also did not seat correctly.Then the shell was instead changed to a trabeculink shell (183-201/48) but neither of the 2 liners still did not seat.A 183-361/32 liner was finally used and it seated correctly.The parts implanted were 183-201/48, lot 220302/0848 with 183-361/32, lot 2323127.The shell and both inserts are being shipped for the investigation." [customer].

• Brand Name: MOBILELINK
• Common Device Name: MOBILELINK ACETABULAR CUP SYSTEM, INSERT, X-LINKED VIT-E PE, I.D.= 32MM, INSERT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 23320612
• Report Number: 3004371426-2025-00051
• Device Sequence Number: 14900280
• Product Code: LPH
• UDI-Device Identifier: 04026575177189
• UDI-Public: 04026575177189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K182321
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: 183-371/32
• Device Catalogue Number: 183-371/32
• Device Lot Number: 2309054
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Age: 55 YR
• Patient Sex: Female