MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S; HIP CERAMIC BALL HEAD

Catalog Number	01.29.212
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019: lot 173300: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 2022-10-25.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 in the complaint: liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot 187911: (b)(4) items manufactured and released on 21-nov-2018.Expiration date: 2023-11-11.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
Revision surgery about 1 month after primary for hip infection.The pathogen is unknown.The surgeon performed a washout and revised the ball head and liner.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8495628
• Report Number: 3005180920-2019-00249
• Device Sequence Number: 1019077
• Product Code: LZO
• UDI-Device Identifier: 07630030809231
• UDI-Public: 07630030809231
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 10/25/2022
• Device Catalogue Number: 01.29.212
• Device Lot Number: 173300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2019
• Initial Report FDA Received Date: 04/09/2019
• 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