MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5; HIP COCR HEAD

Catalog Number 01.25.011

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2019: lot 177464 : (b)(4) items manufactured and released on 27 february 2018.Expiration date: 2023-02-15.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 implants involved ball heads: bipolar head 25060.2850 bipolar head ø28x50 lot.176898 (k091967): (b)(4) items manufactured and released on 01 march 2018.Expiration date: 2023-02-08.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 performed after 2 months from the primary due to pain caused by fractured acetabulum.Prior to the primary surgery, the patient had severe bone loss in her femoral head which in turn caused erosion of her acetabulum.The bipolar head under stress pushed through the acetabular wall.The surgeon revised bipolar head and the cocr head successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5
• Type of Device: HIP COCR 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: 8883103
• MDR Text Key: 153968763
• Report Number: 3005180920-2019-00683
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072857
• 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: 08/12/2019

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: 02/15/2023
• Device Catalogue Number: 01.25.011
• Device Lot Number: 177464
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2018
• 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