MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3; CEMENTLESS STEM

Catalog Number	01.18.173
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-sep-2019.Lot 177360: 96 items manufactured and released on 20-mar-2018.Expiration date: 07.03.2023.No anomalies found related to the problem to date, 97 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: hip revision surgery performed 1 year after cementless total hip arthroplasty.No information concerning patient age, level of activity, health status and presence of comorbidities is available.Fluoroscopic images provided are partial and it is not clear if they refer to primary or revision.On the basis of the limited evidence provided, no conclusion can be drawn.
Event or Problem Description
Revision surgery, after 10 months from the primary due to pain.The patient came in complaining of pain and the cause of the pain was an undersized stem.The surgeon revised the head and stem.When the surgeon was revising the stem, it was observed that the stem had in growth when it was explanted.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9128783
• Report Number: 3005180920-2019-00808
• Device Sequence Number: 19523751
• Product Code: LZO
• UDI-Device Identifier: 07630030804380
• UDI-Public: 07630030804380
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/27/2019

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: 03/07/2023
• Device Catalogue Number: 01.18.173
• Device Lot Number: 177360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/27/2019
• 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