MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER 01.29.201 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S

Model Number	01.29.201
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
No dislocation was observed during the trial stability test (used broach, trial neck and trial head with trial liner in the final shell).However, after inserting the head, dislocation occurred in extension and external rotation of the hip.Bone impingement and interference with other soft tissues were checked, but no such influence was identified.The head size was changed from s to m, and the surgery was successfully completed.The delay was 30 minutes, and the total surgical time was 2 hours.During the 30 minutes, the positioning was adjusted, and the head was removed, though the removal was somewhat difficult.After that, a new trial was performed, and the head was reinserted.
Additional Manufacturer Narrative
Batch review performed on 13 october 2025: lot 2515043: (b)(4) items manufactured and released on 20-jun-2025.Expiration date: 2030-06-02.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.Investigation performed by medacta r&d hip project mananger: from the received information it was not possible to determine the root cause for the dislocation of the 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s lot.2515043 after its implantation.Since the trialing performed with all trial components (broach, trial neck, trial head) may differ slightly from those performed with the final implants, as the position of the final stem may differ from that of the broach, we can only suppose that the trial head ref.01.10.10.110 (ø28s) once assembled with the final stem gave the impression that was well seated.This may have led to the selection of a final head ø28 s instead of ø28m.Moreover, the root cause could also be due to other factors that did not emerge during the analysis given the information available on the 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 investigation does not indicate any potential manufacturing related issue.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER 01.29.201 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S
• 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: 23412829
• Report Number: 3005180920-2025-01044
• Device Sequence Number: 10268983
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/29/2025

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: 01.29.201
• Device Lot Number: 2515043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 37 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian