MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED 01.18.441 AMISTEM-P COLLARED LAT STEM SIZE 1; STEM COLLARED

Model Number 01.18.441

Device Problem Output Problem (3005)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29.12.2021: lot 2000035: (b)(4).Expiration date: 2025-05-11 no anomalies were found related to the problem.(b)(4).

Event Description

The patient came in 6 months after the primary surgery reporting pain and x-rays indicated radiolucency's around the stem, but it was not loose.The surgeon revised the stem head and liner and the surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED 01.18.441 AMISTEM-P COLLARED LAT STEM SIZE 1
• Type of Device: STEM COLLARED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13365844
• MDR Text Key: 286667029
• Report Number: 3005180920-2022-00037
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720304
• UDI-Public: 07630040720304
• 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: 01/27/2022

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 Model Number: 01.18.441
• Device Catalogue Number: 01.18.441
• Device Lot Number: 2000035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2020
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: Black Or African American