MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L

Model Number	01.29.210
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation few months after primary cementless tha, an infection accurs around the acetabulum and the cup is revised.No reason to suspect a faulty or defective device at the origin of this adverse event, whose root cause should be defined as early deep infection.Batch review performed on 10 apr 2026 ball heads: mectacer 01.29.210 mectacer head biolox delta dia.36 12/14-l (k112115) lot.2345140: (b)(4) items manufactured and released on 13-dec-2023.Expiration date: 2028-nov-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact 01.32.3652hct flat pe hc liner d 36/g lot.2503779 (k103721) lot 2503779: (b)(4) items manufactured and released on 01-apr-2025.Expiration date: 2030-mar-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Cup: mpact 3d metal 01.38.060dh acetabular shell d 60 two-hole (k171966) lot.1907450b lot 1907450: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-sep-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.From this lot, (b)(4) items were re-sterilized; as of today, (b)(4) have been sold.Root cause:infection is a known possible complication of any surgery.The root cause can be identified as an early deep infection; there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Revision surgery due to infection after 6 months from primary surgery.The surgeon upsized the mpact 3d metal shell, mpact liner and head.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25077220
• Report Number: 3005180920-2026-00364
• Device Sequence Number: 21519461
• Product Code: LZO
• UDI-Device Identifier: 07630030809217
• UDI-Public: 07630030809217
• Combination Product (Y/N): N
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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
• Operator of Device: Health Professional
• Device Model Number: 01.29.210
• Device Lot Number: 2345140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2023
• 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: Male
• Patient Race: White