MAUDE Adverse Event Report: Limacorporate S.p.A. BIOLOX DELTA; Biolox Delta - Femoral Head Dia 32 mm #L,

Model Number	5010.42.323
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	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No pre-existing anomalies were detected by the check of the device history records of the lot numbers involved.This is the first and only complaint recorded on these lot numbers (25at118, ster.N.2500100, 7011917337).We will submit a final report after the investigation.
Event or Problem Description
Hip revision surgery due to infection performed on (b)(6) 2025.Complaint source reported appearance of hyperemic tumescence with fistulation on the scar upon routine checkup, compatible with acute septic phlebitis.Explantation, multiple swabs and application of antibiotic spacer.Previous surgery was performed on (b)(6) 2025 (due to left femoral neck fracture).The following devices were explanted: delta protr.Liner øint 32mm #m, product code 5886.54.158, lot n.25at118, ster.N.2500100 fem.Modular head - l ø32mm, product code 5010.42.323, lot n.7011917337 patient is female, 48 years old.This event occurred in italy.Note: only the head is cleared in the usa.

• Brand Name: BIOLOX DELTA
• Common Device Name: Biolox Delta - Femoral Head Dia 32 mm #L,
• Manufacturer (Section D): Limacorporate S.p.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23605997
• Report Number: 3008021110-2025-00149
• Device Sequence Number: 13073889
• Product Code: MBL
• UDI-Device Identifier: 08033390179904
• UDI-Public: 08033390179904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 5010.42.323
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 09/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown