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
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-01017
• Device Sequence Number: 7805449
• Product Code: JDI
• UDI-Device Identifier: 07630030805141
• UDI-Public: 07630030805141
• 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: 2023
• Device Explanted Year: 2023
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2024
• Device Catalogue Number: 01.25.015
• Device Lot Number: 1901505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2019
• 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 Age: 61 YR
• Patient Sex: Male