MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 22X43; ACETABULAR BIPOLAR HEAD

Model Number 25060.2243

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13-oct-2020: lot 120244: (b)(4) items manufactured and released on 12-apr-2012.Expiration date: 28-feb-2017.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 since 2016.Additional implant involved: ball heads: cocr 01.25.124 cocr ball head 12/14 ø 22 size s -2,5 (k080885) lot.120541.Batch review performed on 13-oct-2020: lot 120541: (b)(4) items manufactured and released on 06-sep-2012.Expiration date: 28-feb-2017.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 since 2016.

Event Description

The patient came in reporting acetabular discomfort 6 years and 6 months after the primary.The cause of the discomfort is unknown.The surgeon revised the patient's bipolar head and the cocr primary head.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 22X43
• Type of Device: ACETABULAR BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10689619
• MDR Text Key: 211685821
• Report Number: 3005180920-2020-00707
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843358
• UDI-Public: 07630030843358
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 25060.2243
• Device Catalogue Number: 25060.2243
• Device Lot Number: 120244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2012
• 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