MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=20MM - L=200MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By the check of dhrs (device history records) no pre-existing anomalies were detected on the lot number 1500622 involved.This is the first and only complaint registered on the lot number 1500622.A final report will be submitted after the investigation.
Event or Problem Description
The screw between the revision mod.Stem ø20 mm (product code: 3816.15.020, lot: 1500622 - ster: (b)(4)) and the neck (product code: 7515.15.105) became loose post-operatively.Revision surgery performed on (b)(6) 2025.According to the complaint source, it is possible that a small piece of sterile plastic wrapping from the stem became lodged between the stem and the neck; however, this cannot be confirmed the patient underwent the primary surgery in 2016, followed by a first revision on (b)(6) 2018.The second revision surgery was then performed on (b)(6) 2025, which is the procedure related to the current complaint.Patient: male, 100kg, 185cm.Event occurred in switzerland.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=20MM - L=200MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23849590
• Report Number: 3008021110-2025-00167
• Device Sequence Number: 9958691
• Product Code: LZO
• UDI-Device Identifier: 08033390003919
• UDI-Public: 08033390003919
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 3816.15.020
• Device Lot Number: 1500622
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown