MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER HEAD BIOLOX OPTION 32; HIP CERAMIC BALL HEAD

Model Number	01.29.231H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 september 2020.Lot 189670: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-01-21.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.Additional device involved: batch review performed on 02 april 2020: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 1910285: (b)(4) items manufactured and released on 24-jan-2020.Expiration date: 2024-12-09.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.
Event or Problem Description
The patient came in, 2 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner and the surgery was completed successfully.

• Brand Name: MECTACER HEAD BIOLOX OPTION 32
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10566032
• Report Number: 3005180920-2020-00629
• Device Sequence Number: 19509209
• Product Code: LZO
• UDI-Device Identifier: 07630030809330
• UDI-Public: 07630030809330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 09/22/2020

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: 01/21/2024
• Device Model Number: 01.29.231H
• Device Catalogue Number: 01.29.231H
• Device Lot Number: 189670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/22/2020
• 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