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

Model Number	01.29.203
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed after about 1 month from the primary surgery.The pathogen is unknown.The surgeon performed a washout and revised the medacta head and competitor liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 january 2022.Lot 1908980: (b)(4) items manufactured and released on 10-feb-2020.Expiration date: 2025-jan-21.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold and other two similar events have been reported.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L
• Common Device Name: CERAMIC FEMORAL 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: 13340926
• Report Number: 3005180920-2022-00047
• Device Sequence Number: 4100811
• 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): 01/25/2022

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: 01/21/2025
• Device Model Number: 01.29.203
• Device Catalogue Number: 01.29.203
• Device Lot Number: 1908980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2020
• 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: Female