MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT; HIP MODULAR STEM PROXIMAL BODY

Catalog Number	01.22.010
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 jul 2024: lot 1901216: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.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 31 jul 2024: stem: m-vizion 01.22.101 distal stem ø12mm l 140mm straight (k170690) lot 2101124: (b)(4) items manufactured and released on 20-aug-2021.Expiration date: 2026-07-22.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.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2214382: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-09-20.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: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot 2202286: (b)(4) items manufactured and released on 11-apr-2022.Expiration date: 2027-03-13.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
At 1 year and 7 months from the medacta primary surgery, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the competitor cup with a medacta cup, and revised the medacta stem, proximal body, head, liner with medacta implants.The surgery was completed successfully.

• Brand Name: M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT
• Common Device Name: HIP MODULAR STEM PROXIMAL BODY
• 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: 20043509
• Report Number: 3005180920-2024-00647
• Device Sequence Number: 8117357
• Product Code: LZO
• UDI-Device Identifier: 07630030877162
• UDI-Public: 07630030877162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/22/2024

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: 11/24/2024
• Device Catalogue Number: 01.22.010
• Device Lot Number: 1901216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2019
• 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: Male
• Patient Race: Black Or African American