MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0; HIP BALL HEAD

Catalog Number 01.25.031

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 october 2023: lot 186285: (b)(4) items manufactured and released on 07-nov-2018.Expiration date: 2023-10-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Other device involved: stem: quadra-c 01.12.40sn cemented, mirror polished std stem size 0, short neck (k103189) lot 2211699: (b)(4) items manufactured and released on 07-sept-2022.Expiration date: 2027-08-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

Event Description

Revision surgery at about 3 months post primary due to hip infection.The surgeon revised the stem and head from medacta and the acetabular components from competitor.Cement spacer was implanted successfully.

• Brand Name: BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0
• Type of Device: HIP BALL 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18148911
• MDR Text Key: 328286088
• Report Number: 3005180920-2023-00873
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080885
• 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: 11/16/2023

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: 10/24/2023
• Device Catalogue Number: 01.25.031
• Device Lot Number: 186285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2018
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 59 KG