MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BIOLOX DELTA; BIOLOX DELTA - FEMORAL HEAD DIA 28 MM #S

Model Number	5010.42.281
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to aseptic loosening of the acetabular component of the right hip arthroprosthesis.Limacorporate fem.Modular head - s ø28mm (product code: 5010.42.281 - lot.2082434 - ster.(b)(4)) was explanted, together with dedienne legal manufacturer devices acet.Cup cemented sz.48mm / symbol (product code: 3700502203660 - lot.204780040a) and pe-insert 28mm (product code: 3700502203875 - lot: 204482040a).Previous surgery was performed on (b)(6) 2021.Patient 88 years old.Event occurred in italy.
Additional Manufacturer Narrative
The check of device history records did not highlight any pre-existing anomalies on the involved lot number 2082434.This is the first and only complaint reported regarding the lot number 2082434 involved.A final mdr report will be submitted at the end of the investigation.

• Brand Name: BIOLOX DELTA
• Common Device Name: BIOLOX DELTA - FEMORAL HEAD DIA 28 MM #S
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; san daniele del friuli; udine, 33038
• MDR Report Key: 22093980
• Report Number: 3008021110-2025-00068
• Device Sequence Number: 6926023
• Product Code: MBL
• UDI-Device Identifier: 08033390183970
• UDI-Public: 08033390183970
• Combination Product (Y/N): N
• PMA/510(K) Number: K141327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/27/2025

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: 5010.42.281
• Device Lot Number: 2082434
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/28/2025
• 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