MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 3; HIP UNCEMENTED FEMORAL STEM

Model Number 01.18.173

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

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2020: lot 171661: (b)(4) items manufactured and released on 10-jul-2017.Expiration date: 2022-06-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

About 1 year after primary surgery the patient stem was revised for loosening.This is the third revision reported on this patient for different reasons since the primary surgery.The correct date and location for the first revision is not known.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
• Type of Device: HIP UNCEMENTED FEMORAL STEM
• 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: 10486940
• MDR Text Key: 205467394
• Report Number: 3005180920-2020-00574
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804380
• UDI-Public: 07630030804380
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/03/2020

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: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: 01.18.173
• Device Catalogue Number: 01.18.173
• Device Lot Number: 171661
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2017
• 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