MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BIOLOX DELTA; BIOLOX DELTA - FEMORAL HEAD DIA 32 MM #M

Model Number	5010.42.322
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	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip revision surgery due to infection and inflammatory reaction performed on (b)(6) 2023.Previous surgery took place on (b)(6) 2023.During the revision surgery, the following components were explanted: fem.Modular head - m ø32mm 501042322 lot 7011755791.Delta protr.Liner øint 32mm #m 588654158 lot 22at1zq.This event occurred in italy.
Additional Manufacturer Narrative
No pre-existing anomaly was detected by the check of the device history records of the lot number involved.This is the first and only complaint registered on these lot numbers.A final report will be submitted after the conclusion of the investigation.
Event or Problem Description
Hip revision surgery due to infection and inflammaotry reaction perofmed on (b)(6) 2023.Previous surgery took place on (b)(6) 2023.During the revision surgery, the following components were explanted: - fem.Modular head - m ø32mm 501042322 lot 7011755791.- delta protr.Liner øint 32mm #m 588654158 lot 22at1zq.This event occurred in italy.
Additional Manufacturer Narrative
Investigation no pre-existing anomaly was detected by the check of the device history records of the lot number involved.This is the first and only complaint registered on these lot numbers.The following information was requested to the complaint source but never received: - radiographs.- patient clinical data, such as weight, height, bmi, any other pathologies relevant to the analysis.- pathogen responsible for the infection.Without the possibility to analyze these data, no further investigation can be performed, other than the check of the device history records.As no pre-existing anomaly was detected, we can state the involved lot numbers were regularly sterilized before being placed on the market.In conclusion, we cannot determine the cause of the infection and inflammatory reaction reported, however, it does not seem to be product related.Pms data.Based on limacorporate pms data, we estimate a revision rate of ceramic femoral heads (family code 5010.42.Xxx), due to infection, of about (b)(4)%.No corrective actions needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.This is a final mdr report.

• Brand Name: BIOLOX DELTA
• Common Device Name: BIOLOX DELTA - FEMORAL HEAD DIA 32 MM #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: 17086599
• Report Number: 3008021110-2023-00065
• Device Sequence Number: 16825260
• Product Code: LZO
• UDI-Device Identifier: 08033390184045
• UDI-Public: 08033390184045
• Combination Product (Y/N): N
• PMA/510(K) Number: K141327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 5010.42.322
• Device Catalogue Number: 5010.42.322
• Device Lot Number: 7011755791
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/09/2025
• 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