MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M

Model Number	01.29.213
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2026.Ball heads: mectacer 01.29.213 mectacer head biolox delta dia.40 12/14-m (k112115) lot 2522895: (b)(4) items manufactured and released on 24-sep-2025.Expiration date: 08-sep-2030.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 01.32.4052hct flat pe hc liner d 40/g (k103721) lot 2514660: (b)(4) items manufactured and released on 25-jul-2025.Expiration date: 07-jul-2030.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:there is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 3 months from the primary,the patient came in due to a dislocation of the head from the liner and the cause is unknown.The surgeon observed an avulsed rectus femoris and lumbar arthritis, resulting in limited mobility.The mpact d 40/g liner was revised to a double mobility d 28/dmf liner, and the 40 mm biolox delta head (size m) was replaced with a biolox delta head of the same size using a sensitin dm converter.No fall or trauma was reported, and x-rays are unavailable.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M
• 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: 24710934
• Report Number: 3005180920-2026-00263
• Device Sequence Number: 12289596
• Product Code: LZO
• UDI-Device Identifier: 07630030809248
• UDI-Public: 07630030809248
• 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): 03/27/2026

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: 01.29.213
• Device Lot Number: 2522895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2025
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Race: White