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

Model Number	01.29.203
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 1 month after the primary surgery, the surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 november 2021.Lot 2007622: (b)(4) items manufactured and released on 20-oct-2020.Expiration date: 2025-oct-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Another device involved: batch review performed on 30 november 2021: liner: mpact dm 01.32.4248mc dm converter liner f/dm (k131458), lot 2006526: (b)(4) items manufactured and released on 27-nov-2020.Expiration date: 2025-nov-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12998729
• Report Number: 3005180920-2021-00995
• Device Sequence Number: 17458346
• Product Code: LZO
• UDI-Device Identifier: 07630030809149
• UDI-Public: 07630030809149
• 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: 2021
• Device Explanted Year: 2021
• 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): 12/14/2021

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: 10/08/2025
• Device Model Number: 01.29.203
• Device Catalogue Number: 01.29.203
• Device Lot Number: 2007622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2020
• 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