MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 5; HA HIP CEMENTLESS STEM

Catalog Number	01.18.145
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) occurred 3 years after primary cementless total hip arthroplasty.Radiographic image provided shows the presence of radiolucent lines in gruen zones 1, 2, 6 and 7 and signs of stress shielding suggesting stem mobilization.Aseptic loosening is a possible literature described adverse event after cementless hip replacement and causes are often unknown.The reason of this event cannot be determined.Batch review performed on 12 november 2018.Lot 152132: (b)(4) items manufactured and released on 20 august 2015.Expiration date: 2020-07-14.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 or Problem Description
On oct 15, 2018 we were informed that 2 years and 10 months after primary the patient came in complaining of pain.On (b)(6) 2108 the surgeon revised the hip for a stem potting (distal fixation + proximal radiolucency).Stem, head and liner swap.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 5
• Common Device Name: HA HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8064115
• Report Number: 3005180920-2018-00885
• Device Sequence Number: 2463833
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2020
• Device Catalogue Number: 01.18.145
• Device Lot Number: 152132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/13/2018
• 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