MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX OPTION HEADS; MECTACER HEAD BIOLOX OPTION 12/14 Ø 40

Model Number	01.29.233H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 december 2025.Ball heads: mectacer 01.29.233h mectacer head biolox option 12/14 d40 (k131518) lot: 2406574: (b)(4) items manufactured and released on 04-apr-2024.Expiration date: 19-mar-2029.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 01.32.156mh acetabular shell d 56 multi-hole (k132879) lot: 2348587: (b)(4) items manufactured and released on 14-may-2024.Expiration date: 29-apr-2029.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 01.32.4048hct flat pe hc liner d 40/f (k103721) lot: 2306064: (b)(4) items manufactured and released on 26-jul-2023.Expiration date: 10-jul-2028.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.Stem: sms solid 01.36.069 sms solid stem lat size 9 (k181693) lot: 2406334: (b)(4) items manufactured and released on 11-apr-2024.Expiration date: 27-mar-2029.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.Root cause:infection is a known possible complication of any surgery.Although no root cause can be established, 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
At about 1 year from the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted new hardware.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX OPTION HEADS
• Common Device Name: MECTACER HEAD BIOLOX OPTION 12/14 Ø 40
• 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: 23758549
• Report Number: 3005180920-2025-01233
• Device Sequence Number: 10084128
• Product Code: LZO
• UDI-Device Identifier: 07630030809354
• UDI-Public: 07630030809354
• Combination Product (Y/N): N
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 12/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: 01.29.233H
• Device Lot Number: 2406574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 129 KG