MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; HIP CEMENTLESS STEM

Catalog Number	01.18.137
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: femoral component revision surgery performed 6 years after cementless total hip arthroplasty.No information concerning patient age, general health status and comorbidities is available.Radiographic image provided shows an abnormal bone reaction but no element is available to define the causes of this.The reason of this event cannot be determined on the basis of information collected.There is no reason to suspect a faulty device.Batch review performed on 29-july-2019 by regulatory affairs department.Lot 110559: (b)(4) items manufactured and released on 13-apr-2011.Expiration date: 2016-03-31.(b)(4) item has been resterilized and released on 07-oct-2015, expiration date 2020-09-15.No anomalies found related to the problem.(b)(4) items have been resterilized and released on 26-july-2016, expiration date 2021-07-06.(b)(4) item has been resterilized and released on 24-oct-2016, expiration date 2021-10-03.(b)(4) item has been resterilized and released on 23-nov-2016, expiration date 2021-11-08.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a loose stem.The surgeon revised the stem and head 6 years and 1 month after primary.The surgery was completed successfully.We were informed about the event on august 20th, the revision surgery has been performed on august 26th.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8906041
• Report Number: 3005180920-2019-00688
• Device Sequence Number: 2267475
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 08/19/2019

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: 03/31/2016
• Device Catalogue Number: 01.18.137
• Device Lot Number: 110559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2019
• Initial Report FDA Received Date: 08/19/2019
• 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