MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LCU Hip System; Hip Prosthesis Stem, cementless, PoroLink, L= 170 mm, Sz. 16, standard, CCD 130°

Model Number	165-320/26
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of the prosthesis neck "[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: LCU Hip System
• Common Device Name: Hip Prosthesis Stem, cementless, PoroLink, L= 170 mm, Sz. 16, standard, CCD 130°
• 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: 24659613
• Report Number: 3004371426-2026-00027
• Device Sequence Number: 17422593
• Product Code: LZO
• UDI-Device Identifier: 04026575166909
• UDI-Public: 04026575166909
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K161840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 10/31/2024
• Device Model Number: 165-320/26
• Device Catalogue Number: 165-320/26
• Device Lot Number: 1941076
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male