MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H STEM COLLARED HA COATED STD STEM SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.18.233
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2019: lot 151474: (b)(4) items manufactured and released on 03-aug-2015.Expiration date: 06-30-2020.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.Clinical evaluation performed on 24 july 2019: femoral component revision surgery performed 1 year and 9 moths after cementless total hip arthroplasty.Information concerning patient age, weight and health status is not available.The radiographic images provided show the presence of radiolucent lines in gruen zones 1 and 7 and stem looks slightly undersized.The reason of this choice is unknown: patient anatomy or bone morphology may be a possible cause but this cannot be determined on the basis of pre-revison x-rays.Aseptic loosening is a possible literature described adverse event following cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed after 1 year and 10 months from the primary due to pain caused by mobilized stem.The stem mobilization caused instability what caused that the patient fall and fractured the femur.The stem has been revised successfully.

• Brand Name: AMISTEM H STEM COLLARED HA COATED STD STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8825503
• Report Number: 3005180920-2019-00616
• Device Sequence Number: 2860205
• Product Code: LZO
• UDI-Device Identifier: 07630030804588
• UDI-Public: 07630030804588
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 01.18.233
• Device Lot Number: 151474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention