MAUDE Adverse Event Report: LIMACORPORATE S.P.A. H-MAX S STEM; H-MAX S STEM - STANDARD - TAPER 12/14 #13 H.155MM

Model Number	4250.20.130
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	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records (dhrs) and sterilization charts for the involved lot numbers 2307316, 23at2b0, 2413576 and 2318969 have been reviewed; no pre-existing anomalies were identified.The dhr review for lot number 7011770046 has been requested from the third-party supplier.A final report will be submitted once the investigation has been completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2026 due to infection.The previous surgery was done on (b)(6) 2024.The following devices were explanted: liner #l for mobile liner ø42 (product code: 5885.09.042, lot: 2307316 - ster: 2300105).Mobile liner øint 28 mm ø42 mm (product code: 5566.54.420, lot: 23at2b0 - ster: 2300202).Fem.Modular head - s ø28mm (product code: 5010.42.281, lot: 7011770046).Delta-tt acetab.Cup ø56 mm (product code: 5552.15.560, lot: 2413576 - ster: 2400143).H-max s standard fem.Stem #13 (product code:4250.20.130, lot: 2318969 - ster: 2300205).Event occurred in italy.

• Brand Name: H-MAX S STEM
• Common Device Name: H-MAX S STEM - STANDARD - TAPER 12/14 #13 H.155MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24377827
• Report Number: 3008021110-2026-00126
• Device Sequence Number: 17378820
• Product Code: KWY
• UDI-Device Identifier: 08033390298926
• UDI-Public: 08033390298926
• Combination Product (Y/N): N
• PMA/510(K) Number: K160011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 4250.20.130
• Device Catalogue Number: 4250.20.130
• Device Lot Number: 2318969
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/18/2026
• 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