MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD Ø28X44; HIP BIPOLAR HEAD

Catalog Number 25060.2844

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 february 2019: lot 181370: (b)(4) items manufactured and released on 23-jul-2018.Expiration date: 2023-07-02.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: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot 182500: (b)(4) items manufactured and released on 05-jul-2018.Expiration date: 2023-06-21.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.

Event Description

Revision surgery and washout performed one month after primary surgery due to signs of infection (the pathogen is unknown).The bipolar head and the cocr head have been revised.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD Ø28X44
• Type of Device: HIP BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8377330
• MDR Text Key: 137365445
• Report Number: 3005180920-2019-00111
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843594
• UDI-Public: 07630030843594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2023
• Device Catalogue Number: 25060.2844
• Device Lot Number: 181370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention