MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LCU - HIP SYSTEM; LCU HIP STEMS, CEMENTLESS, STANDARD TYPE, TI6AL4V, HX COATING, TAPER 12/14,

Model Number	165-018/26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
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
Periprosthetic fracture.

• Brand Name: LCU - HIP SYSTEM
• Common Device Name: LCU HIP STEMS, CEMENTLESS, STANDARD TYPE, TI6AL4V, HX COATING, TAPER 12/14,
• 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: 16672564
• Report Number: 3004371426-2023-00017
• Device Sequence Number: 6642020
• Product Code: LZO
• UDI-Device Identifier: 04026575415342
• UDI-Public: 04026575415342
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K213770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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 Model Number: 165-018/26
• Device Catalogue Number: 165-018/26
• Device Lot Number: 2215173
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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 Sex: Male