MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5; HIP CEMENTLESS STEM

Catalog Number 01.18.405

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 21 july 2020: lot 183747: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-09-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any other similar reported event.

Event Description

The patient came in 1year and 3 months after the primary surgery reporting thigh pain which was caused by a loose stem.The surgeon revised the medacta stem and head with another company's product and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10366565
• MDR Text Key: 201695407
• Report Number: 3005180920-2020-00487
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• 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: Other
• Type of Report: Initial
• Report Date: 08/05/2020

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: No Information
• Device Expiration Date: 09/25/2023
• Device Catalogue Number: 01.18.405
• Device Lot Number: 183747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2018
• 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