MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

Model Number	01.29.211
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 june 2025.Lot 2402933: (b)(4) items manufactured and released on 26-feb-2024.Expiration date: 2029-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional device involved: batch review performed on 16 june 2025.Cup: mpact 01.32.162dh acetabular shell ø62 two-holes (k132879) lot 2336197: (b)(4) items manufactured and released on 11-sep-2023.Expiration date: 2028-08-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot 2218074: (b)(4) items manufactured and released on 17-nov-2022.Expiration date: 2027-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events 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
At about 7 months after the primary, the patient came in reporting pain due to a dislocation of the head from the liner and the cause of the dislocation is unknown.The surgeon revised the cup, head and liner.Cup was revised because it looked like it was vertical and not anteverted enough to the surgeon (cause unknown).The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL
• 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: 22410970
• Report Number: 3005180920-2025-00616
• Device Sequence Number: 9692816
• Product Code: LZO
• UDI-Device Identifier: 07630030809224
• UDI-Public: 07630030809224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: 01.29.211
• Device Lot Number: 2402933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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 Sex: Male