MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED STD STEM SIZE 4; HIP STEM

Catalog Number 01.18.434

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 april 2024.Lot: 2012840: (b)(4) items manufactured and released on 12-mar-2021.Expiration date: 2026-03-01.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

Event Description

At about 2 years from the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-P COLLARED STD STEM SIZE 4
• Type of Device: HIP STEM
• 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: 19178383
• MDR Text Key: 341002235
• Report Number: 3005180920-2024-00247
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173794
• 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: 04/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.434
• Device Lot Number: 2012840
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2021
• 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