MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S; HIP DELTA CERAMIC BALL HEAD

Model Number	01.29.212
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6)2023 lot 2217243: (b)(4) items manufactured and released on 18-oct-2022.Expiration date: 2027-10-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other device involved: liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot 2246667: (b)(4) items manufactured and released on 30-jan-2023.Expiration date: 2028-01-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
After the primary hip surgery, in post-op recovery, the patient suffered a joint luxation.The surgeon revised the cup, liner, and head.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
• Common Device Name: HIP DELTA 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: 17036591
• Report Number: 3005180920-2023-00380
• Device Sequence Number: 12520227
• Product Code: LZO
• UDI-Device Identifier: 07630030809231
• UDI-Public: 07630030809231
• 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): 06/01/2023

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 Model Number: 01.29.212
• Device Catalogue Number: 01.29.212
• Device Lot Number: 2217243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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