MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L

Model Number	01.29.203
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-mar-2023: lot 189637: (b)(4) items manufactured and released on 19-feb-2019.Expiration date: 2024-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Another device involved: batch review performed on 23-mar-2023: liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265)lot.2009651: (b)(4) items manufactured and released on 26-oct-2020.Expiration date: 2025-10-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
The patient came in due to signs of an infection 21 days after the primary surgery, the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11568442
• Report Number: 3005180920-2021-00234
• Device Sequence Number: 19732736
• Product Code: LZO
• UDI-Device Identifier: 07630030809149
• UDI-Public: 07630030809149
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 03/25/2021

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: 02/05/2024
• Device Model Number: 01.29.203
• Device Catalogue Number: 01.29.203
• Device Lot Number: 189637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention