MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5; HIP BALL HEAD

Catalog Number 01.25.015

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 november 2023 lot 1901505: (b)(4) items manufactured and released on 26-jun-2019.Expiration date: 2024-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: liner: mpact dm 01.26.2852mhc double mobility hc liner 28/dmf (k092265) lot 2302832: 77 items manufactured and released on 12-apr-2023.Expiration date: 2028-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact dm 01.32.4452cf dm converter tin coated g/dmf (k211891) lot 2249471: 20 items manufactured and released on 03-may-2023.Expiration date: 2028-04-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Previous mdr sent: 2022-00637 2022-00696 2023-00238 2023-00737 2023-00918.

Event Description

The patient had a primary hip surgery on 18 dec 2019.Subsequently, the head dislocated from the liner.On (b)(6) 2022, the surgeon revised the head and liner.Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2022, the surgeon performed a washout and revised the head and liner.Subsequently, the patient came in due to signs of infection and the pathogen was unknown.On (b)(6) 2023, the surgeon performed a washout, revised all implants.Subsequently, the patient came in sue to signs of infection and the pathogen was unknown.On (b)(6) 2023, the surgeon performed a washout, revised all implants.Subsequently, the patient came in due to a dislocation of the head from the liner.On (b)(6) 2023, the surgeon revised the head and liner and implanted a dm converter.Presently, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the head, liner and dm converter.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5
• 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: 18371294
• MDR Text Key: 331084832
• Report Number: 3005180920-2023-01017
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030805141
• UDI-Public: 07630030805141
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2023

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 Catalogue Number: 01.25.015
• Device Lot Number: 1901505
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• 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: 61 YR
• Patient Sex: Male