MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4

Catalog Number	01.29.206
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on 23 march 2023.On (b)(6) 2023, 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 liner and head.The surgery was completed successfully.Presently, on (b)(6) 2023, 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.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 november 2023: lot 21c0007: 28 items manufactured and released on 15-june-2021.Expiration date: 2026-05-30.No anomalies found related to the problem.To date, 19 items of the same lot have been sold without any similar reported event during the period of review.Additional device involved batch review performed on 08 november 2023: liner: impact 01.32.3241hc10a face-changing 10° pe hc liner ø32/d (k183582) lot 1911122: 20 items manufactured and released on 11-feb-2020.Expiration date: 2025-01-25.No anomalies found related to the problem.To date, 10 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4
• Common Device Name: CERAMIC BALL HEAD
• 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: 18198433
• Report Number: 3005180920-2023-00921
• Device Sequence Number: 6445212
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• 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: 2023
• Device Explanted Year: 2023
• 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): 11/23/2023

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 Expiration Date: 05/30/2026
• Device Catalogue Number: 01.29.206
• Device Lot Number: 21C0007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2021
• 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: Female