MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S

Model Number	01.29.204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2025 ball heads: mectacer 01.29.204 mectacer head biolox delta dia.32 12/14-s (k112115) lot 2513531: (b)(4) items manufactured and released on 10-july-2025.Expiration date: 2030-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.3241hct flat pe hc liner d 32/d (k103721) lot 2507643: (b)(4) items manufactured and released on 02-april-2025.Expiration date: 2030-03-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 20 days after the primary, the patient came in reporting pain due to a dislocation of the head from the liner, and the cause is unknown.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.32 12/14-S
• 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: 23510651
• Report Number: 3005180920-2025-01126
• Device Sequence Number: 9770177
• Product Code: LZO
• UDI-Device Identifier: 07630030809156
• UDI-Public: 07630030809156
• 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: 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): 11/10/2025

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: 01.29.204
• Device Lot Number: 2507643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2025
• 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: Female
• Patient Race: White