MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=18MM - L=200MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the device history records (dhrs) for the involved lot numbers did not reveal any pre existing anomalies.All units were released to the market in full compliance with the applicable specifications.This is the first and only complaint received for these lot numbers.A final report will be issued upon completion of the ongoing investigation.
Event or Problem Description
Revision surgery performed on (b)(6) 2026 due to loosening, with possible septic involvement.The following devices were removed: revision modular neck h.70mm (product code: 7515.15.020, lot: 1807325 - (b)(6).Revision mod.Stem ø18mm (product code: 3814.15.020, lot: 1807836 - (b)(6)).Head and poly liner (product codes and lot numbers are unknown) previous surgery occurred on year 2018 (exact date unknown).Patient: 79 years old.Event occurred in italy.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=18MM - L=200MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24377892
• Report Number: 3008021110-2026-00127
• Device Sequence Number: 14687845
• Product Code: LZO
• UDI-Device Identifier: 08033390003896
• UDI-Public: 08033390003896
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 3814.15.020
• Device Lot Number: 1807836
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/18/2026
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown