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

Model Number	01.29.203
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 april 2020: lot 151722: (b)(4) items manufactured and released on 05-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem since 2016.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Additional device involved: batch review performed on 03 april 2020: lot 1905489: (b)(4) items manufactured and released on 13-sep-2019.Expiration date: 2024-08-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: repeated infection in tha, few weeks after last operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
One month after a previous revision surgery, the patient came in duo to signs of infection.The surgeon revised the head and liner and the surgery was completed successfully.The pathogen is unknown.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9980338
• Report Number: 3005180920-2020-00249
• Device Sequence Number: 4597400
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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: 06/30/2020
• Device Model Number: 01.29.203
• Device Catalogue Number: 01.29.203
• Device Lot Number: 151722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/21/2020
• 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