MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 8; CEMENTLESS HIP STEM

Catalog Number 01.18.178

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 july 2018: lot 171674: (b)(4) items manufactured and released on 30 august 2017.Expiration date: 2022-08-17.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of pain 1 month after primary.The surgeon determined that the patient fractured near the distal end of the stem.The surgeon revised the stem and head with another company's product.The cup and liner remain in place.The surgery was completed successfully.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 8
• Type of Device: CEMENTLESS 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7726662
• MDR Text Key: 115238540
• Report Number: 3005180920-2018-00571
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804434
• UDI-Public: 07630030804434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161635
• 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: 07/27/2018

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 Expiration Date: 08/17/2022
• Device Catalogue Number: 01.18.178
• Device Lot Number: 171674
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2017
• 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