MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR 12/14 Ø 28 SIZE XL +7; HIP BALL HEAD

Catalog Number	01.25.014
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 april 2024: lot 164839b: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 2026-11-16.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.Additional devices involved: batch reviews performed on 18 april 2024: liner: versafitcup dm 01.26.2858mhc double mobility hc liner ø 58/28 (k092265) lot 1909381: 50 items manufactured and released on 13-dec-2019.Expiration date: 2024-12-02.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.Cup: versafitcup 01.26.58mb acetabular shell ø 58 (k083116) lot 1906138:(b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-03-02.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.
Event or Problem Description
The patient underwent primary surgery on (b)(6) 2022.On (b)(6) 2022, the patient has been revised the first time because of surgical wound issues.Ceramic ball head ø36 size xl and liner ø36/e revised successfully and the surgeon implanted ceramic ball head (ø36 size xl) and pe liner.On (b)(6) 2022, the patient underwent a second revision surgery due to joint luxation.Ball head, liner and acetabular shell have been successfully revised and versafitcup dm ø58mm, liner dm ø28/58mm dmi and cocr ball head ø28 size xl (+7) were implanted.On (b)(6) 2022, the patient has been revised because of infection and the surgeon performed a washout with revision of mobile parts of the prosthesis.

• Brand Name: BALL HEADS: COCR 12/14 Ø 28 SIZE XL +7
• 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: 19249219
• Report Number: 3005180920-2024-00291
• Device Sequence Number: 7320964
• Product Code: JDI
• UDI-Device Identifier: 07630030805134
• UDI-Public: 07630030805134
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/06/2024

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 Catalogue Number: 01.25.014
• Device Lot Number: 164839B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 115 KG