MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX OPTION HEADS; HEAD BIOLOX OPTION Ø 36

Model Number	01.29.232H
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 july 2025 mectacer 01.29.232h mectacer head biolox option 12/14 ø 36 (k131518) lot.2429403: 30 items manufactured and released on 06-nov-2024.Expiration date: 2029-10-22.No anomalies found related to the problem.To date, 25 items of the same lot have been sold with a similar reported event during the period of review.Additional component involved and revised: batch review performed on 31 july 2025.Liner: mpact 01.32.3644hc10a face chang 10° pe hc liner ø36/e (k183582) lot.2344524: (b)(4) items manufactured and released on 21-dec-2023.Expiration date: 2028-12-09.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with a similar reported event during the period of review.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
The patient had a primary hip surgery on (b)(6) 2018.On (b)(6) 2025, the patient came in reporting pain and instability due to a leg length discrepancy and lack of offset.The surgeon revised the head and liner and the surgery was completed successfully.Presently, on (b)(6) 2025, the patient presented to er with a dislocation of the head from the liner and the cause is unknown.The surgeon revised the medacta head to a new medacta cocr head and revised the medacta liner to a stryker semi-constrained liner to prevent future dislocation.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX OPTION HEADS
• Common Device Name: HEAD BIOLOX OPTION Ø 36
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22792527
• Report Number: 3005180920-2025-00776
• Device Sequence Number: 8808701
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 01.29.232H
• Device Lot Number: 2429403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: 88 YR
• Patient Sex: Female
• Patient Race: White