MAUDE Adverse Event Report: LIMACORPORATE S.P.A. FEMORAL HEAD; FEMORAL HEAD - DIA.32MM SHORT TAPER 12/14

Model Number	5010.42.321
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint source reported revision due to infection performed on (b)(6) 2025.Previous surgery performed on (b)(6) 2015.Patient 49 years old.The devices explanted are the following: · delta protr.Liner øint 32mm #m (product code: 588651158, lot: 1509428 - ster: (b)(4) - sold in us.· bone screw ø6,5 h.25mm (product code: 8420.15.020, lot: 1507404 - ster: (b)(4)) - sold in us.· sam-fit right mod.Fem.Stem #1 (product code: 4216.25.110, lot: 1103050 - ster: (b)(4)) - not sold in us.· modular neck std-s (s1) (product code: 4220.09.110, lot: 1512295 - ster: (b)(4)) - not sold in us.· fem.Modular head - s ø32mm (product code: 5010.42.321, lot: 1482052 - ster: (b)(4)) - sold in us.· delta-pf acetab.Cup ø50 mm (product code: 5551.25.500, lot: 1500348 - ster: (b)(4)) - not sold in us.· bone screw ø6,5 h.20mm (product code: 8420.15.010, lot: 1507399 - ster: (b)(4)) - sold in us.
Additional Manufacturer Narrative
The check of device history records (dhrs) did not highlight any pre-existing anomalies on the lot numbers involved.This is the first and only complaint received about these lot numbers.A final report will be submitted once the investigation is completed.

• Brand Name: FEMORAL HEAD
• Common Device Name: FEMORAL HEAD - DIA.32MM SHORT TAPER 12/14
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23692504
• Report Number: 3008021110-2025-00158
• Device Sequence Number: 9124041
• Product Code: MBL
• UDI-Device Identifier: 08033390298100
• UDI-Public: 08033390298100
• Combination Product (Y/N): N
• PMA/510(K) Number: K1413274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 11/27/2025

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: 5010.42.321
• Device Catalogue Number: 5010.42.321
• Device Lot Number: 1482052
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/02/2025
• 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