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	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 may 2026: mectacer 01.29.204 mectacer head biolox delta dia.32 12/14-s (k112115) lot.2520668: (b)(4) items manufactured and released on 03-sep-2025.Expiration date: 2030-jul-30.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.Mpact 01.32.3237hct flat pe hc liner d 32/b (k112115) lot.2526515: (b)(4) items manufactured and released on 26-nov-2025.Expiration date: 2030-nov-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.R&d analysis visual inspection performed on 29 april 2026.From the received part it was not possible to determine the root cause of the event; no implant defects were noticed on the device and the only visible sign was a black spot probably occurred during the revision and the contact with the metallic instruments.Root cause: from the received part and the available information, it was not possible to determine a definitive root cause of the event; no implant defects were observed on the device, the only visible sign being a black spot likely caused during the revision due to contact with metallic instruments, and the device history record review does not indicate any potential manufacturing-related issue nor any evidence that the device may have caused or contributed to the event.
Event or Problem Description
Revision surgery due to implant dislocation after about 2 months from the primary surgery.During the surgery the head was changed from size s to size m.

• 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: 25123205
• Report Number: 3005180920-2026-00379
• Device Sequence Number: 15611902
• 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: 2026
• 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): 05/08/2026

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: 01.29.204
• Device Lot Number: 2520668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian