MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION 36; CERAMIC HEAD OPTION

Model Number	01.29.232H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 24 july 2020: lot 19c0067: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-27.All lot was resterilized on 03.12.2019.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer 01.29.241a sleeve size m (k131518) lot.19c0073.Batch review performed by medacta regulatory affairs department on 24 july 2020: lot 19c0073: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-27.All lot was resterilized on 02.12.2019.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient has developed an infection in the hip following revision surgery performed 1 month before.The type of pathogen is unknown.The surgeon performed a washout.The ball head was revised.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION 36
• Common Device Name: CERAMIC HEAD OPTION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10366326
• Report Number: 3005180920-2020-00519
• Device Sequence Number: 2345181
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131518
• 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): 08/05/2020

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: 11/27/2024
• Device Model Number: 01.29.232H
• Device Catalogue Number: 01.29.232H
• Device Lot Number: 19C0067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 08/05/2020
• 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
• Patient Age: 59 YR
• Patient Weight: 113