MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M-VIZION PROXIMAL BODY Ø20MM L 40MM LAT WITH HOLES; HIP CEMENTLESS MODULAR STEM PROXIMAL BODY PART

Catalog Number 01.22.407

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 december 2023: lot: 2101193: (b)(4) items manufactured and released on 18-feb-2022.Expiration date: 2027-feb-10.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 device involved batch review performed on 21 december 2023: liner: mpact dm 01.26.2856mhc double mobility hc liner ø28/dmh (k092265) lot: 2245580: (b)(4) items manufactured and released on 24-jan-2023.Expiration date: 2028-jan-04.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: 2218763: (b)(4) items manufactured and released on 02-nov-2022.Expiration date: 2027-oct-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.

Event Description

The patient had a primary hip surgery on (b)(6) 2023.Subsequently, the patient came in reporting pain due to a periprosthetic fracture that was caused by falling.On (b)(6) 2023, the surgeon cabled the fracture and revised the stem, head, and liner.Presently, on (b)(6) 2023, the patient came in reporting pain due to a leg length discrepancy.The surgeon revised the proximal body, head and liner and the surgery was completed successfully.

• Brand Name: M-VIZION PROXIMAL BODY Ø20MM L 40MM LAT WITH HOLES
• Type of Device: HIP CEMENTLESS MODULAR STEM PROXIMAL BODY PART
• 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: 18453081
• MDR Text Key: 332262754
• Report Number: 3005180920-2023-01073
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.22.407
• Device Lot Number: 2101193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male