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

Model Number	5010.42.282
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to hip fracture.Issue was reported to have involved the fem.Modular head - m ø28mm (part number: 5010.42.282, lot: 1781396, sterilization: 2200312) and surgeon implanted delta cup mobile liner dia 42mm for heads dia 28mm (part number: 5566.50.420) during revision to solve the issue.Previous surgery was performed on (b)(6) 2024.Patient is male, date of birth on (b)(6) 1950.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records did not identify any pre-existing anomaly or nonconformity that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: BIOLOX DELTA HEAD
• Common Device Name: BIOLOX DELTA HEAD 28MM #M
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 23789485
• Report Number: 3008021110-2025-00166
• Device Sequence Number: 20261819
• Product Code: LZO
• UDI-Device Identifier: 08033390007184
• UDI-Public: 8033390007184
• Combination Product (Y/N): N
• PMA/510(K) Number: K141327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/11/2025

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: 5010.42.282
• Device Lot Number: 1781396
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• 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