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

Catalog Number	01.29.230H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 july 2019: lot 19c0002: (b)(4) items manufactured and released on 31.01.2019.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 liner: versafitcup dm 01.26.2850mhc double mobility hc liner 28/dme (k092265) lot.1810742.Batch review performed on 22 july 2019: lot 1810742: (b)(4) items manufactured and released on 12.02.2019.Expiration date: 2024-01-27.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.Additional implant involved ball heads: mectacer 01.29.243a sleeve size xl (k131518) lot.189675.Batch review performed on 22 july 2019: lot 189675: (b)(4) items manufactured and released on 27.02.2019.Expiration date: 2024-02-19.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 performed 15 days from the primary due to an infection (the pathogen is unknown).The surgeon performed an i&d and revised the head, liner, and sleeve and the surgery was completed successfully.

• Brand Name: 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: 8841135
• Report Number: 3005180920-2019-00652
• Device Sequence Number: 19182573
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 19C0002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/30/2019
• 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