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

Model Number	01.29.206
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary left hip surgery on (b)(6) 2016.On (b)(6) 2024, 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 (mdr (b)(4)).On (b)(6) 2025, 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 biolox head and hooded liner to a cocr head and contrained liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20 november 2025.Ball heads: mectacer 01.29.206 mectacer head biolox delta dia.32 12/14-l (k112115) lot 2302547: (b)(4) items manufactured and released on 22-feb-2023.Expiration date: 01-feb-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.Liner: mpact 01.32.3241hcat hooded pe hc liner d 32/d (k103721) lot 2305350: 72 items manufactured and released on 17-apr-2023.Expiration date: 28-mar-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.Clinical evaluation approximately 2 years after revision tha caused by hip dislocation on a paitent with multi-level spinal fusion, the hip dislocates again and the surgeon decides to choose a constrained liner.The cause for dislocation cannot be determined with certainty based on the information at hand, but it is known that patients with spinal fusions are at higher risk of such adverse events, more so if the fusion concerns several lumbar levels.There is no reason to suspect a faulty device at the origin of this adverse event.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.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER HEAD BIOLOX DELTA DIA.32 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: 23694043
• Report Number: 3005180920-2025-01186
• Device Sequence Number: 9082658
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• Combination Product (Y/N): N
• PMA/510(K) Number: K112115
• 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): 12/02/2025

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: 01.29.206
• Device Lot Number: 2302547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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 Age: 77 YR
• Patient Sex: Female