MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=18MM - L=140MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of device history records of the involved lot number 1707533 did not highlight any pre-existing anomalies on the pieces manufactured.This is the first and only complaint received regarding this lot number.A final report will be submitted after the investigation is completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2026 due to loosening of the femoral revision mod.Stem ø18mm (product code: 3814.15.010, lot: 1707533 - ster: 2200224).During revision the stem with revision later.Neck h.60mm (product code: 7515.15.110, lot: 2202563 - ster: 2200085) were explanted.Cemented stem was implanted.Patient: female, 82 years old.Previous surgery was performed on (b)(6) 2023.Event occurred in italy.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=18MM - L=140MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25589717
• Report Number: 3008021110-2026-00259
• Device Sequence Number: 18640747
• Product Code: LPH
• UDI-Device Identifier: 08033390003889
• UDI-Public: 08033390003889
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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
• Device Model Number: REVISION HIP - TI6AL4V
• Device Catalogue Number: : 3814.15.010
• Device Lot Number: 1707533
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown