MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 32SIZE S -3.5; HIP METALLIC BALL HEAD

Catalog Number	01.25.011
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner that was caused from falling.The surgeon revised the cup, head, and liner.The surgery was completed successfully.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.(mdr 3005180920-2022-00216).Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 september 2023.Lot 2011588: (b)(4) items manufactured and released on 02-mar-2021.Expiration date: 2026-02-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional device involved: liner: versafitcup dm 01.26.2850mhc double mobility hc liner diam 50/28 (k092265) lot 2101757: (b)(4) items manufactured and released on 06-may-2021.Expiration date: 2026-04-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.

• Brand Name: COCR BALL HEAD 12/14 Ø 32SIZE S -3.5
• Common Device Name: HIP METALLIC 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: 17868927
• Report Number: 3005180920-2023-00774
• Device Sequence Number: 5953836
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2026
• Device Catalogue Number: 01.25.011
• Device Lot Number: 162360B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 125 KG