MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø28 MM SIZE XXL; HIP COCR BALL HEAD

Catalog Number	01.25.015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 months after the primary, the patient came in reporting pain and the cause of pain is unknown.The surgeon revised the dm liner with an offset liner, and revised the cocr head with a biolox head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 july 2024.Lot 133979c: (b)(4) items manufactured and released on 23-jan-2019.Expiration date: 2024-01-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional implant revised.Batch review performed on 31 july 2024 on liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot.2100181.Lot 2100181: (b)(4) items manufactured and released on 17-march-2021.Expiration date: 2026-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø28 MM SIZE XXL
• Common Device Name: HIP COCR 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: 19936759
• Report Number: 3005180920-2024-00652
• Device Sequence Number: 18000423
• Product Code: JDI
• UDI-Device Identifier: 07630030805141
• UDI-Public: 07630030805141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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: 01/15/2024
• Device Catalogue Number: 01.25.015
• Device Lot Number: 133979C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2019
• 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 Sex: Unknown