MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28; CERAMIC BALL HEAD

Catalog Number	01.29.230H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 august 2019: lot 19c0001: (b)(4) items manufactured and released on 30-jan-2019.Expiration date: 2024-01-16.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 implant involved: ball heads: mectacer 01.29.243a head biolox option ø 28 (k131518), lot.19c0023.Batch review performed on 16 august 2019: lot 19c0023: (b)(4) items manufactured and released on 31-jan-2019.Expiration date: 2024-01-17.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 implant involved: liner: versafitcup dm 01.26.2854mhc double mobility hc liner 28/dmg (k092265), lot.1810746.Batch review performed on 16 august 2019: lot 1810746: (b)(4) items manufactured and released on 05-feb-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 with one other similar reported event.
Event or Problem Description
The patient came in, 3 weeks after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon revised the medacta 28mm biolox option head with a 28mm biolox option head, a medacta biolox option sleeve xl with a biolox option sleeve xl and a medacta versafitcup dm liner hc 54/28 with a versafitcup dm liner hc 54/28.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8979021
• Report Number: 3005180920-2019-00757
• Device Sequence Number: 11608103
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• 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: 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): 09/10/2019

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: 01/16/2024
• Device Catalogue Number: 01.29.230H
• Device Lot Number: 19C0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/10/2019
• 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