MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0; HIP CERAMIC BALL HEAD

Catalog Number	01.29.205
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024 and while in post-operative recovery, the head dislocated from the liner.The surgeon revised the 32mm biolox delta head with a 32mm biolox option head and added an option sleeve.The surgery was completed successfully.An amis approach was used in the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 31 july 2024 lot 2402178: (b)(4) manufactured and released on 14-feb-2024.Expiration date: 2029-01-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional implant revised.Batch review performed on 31 july 2024 on liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.2336922 lot 2336922: (b)(4) manufactured and released on 22-sep-2023.Expiration date: 2028-09-07.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0
• Common Device Name: HIP 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: 19936761
• Report Number: 3005180920-2024-00632
• Device Sequence Number: 20691211
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• 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: 2024
• 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): 08/08/2024

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 Catalogue Number: 01.29.205
• Device Lot Number: 2402178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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: Female