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

Model Number	01.18.143
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06-april-2020: lot 141478: (b)(4) items manufactured and released on 10-jun-2014.Expiration date: 30.04.2019.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) occurred 5 years and 4 months after cementless total hip arthroplasty in an elderly man ((b)(6) year old).No information concerning patient general health status or presence of comorbidities is available.Radiographic images provided show the presence of bone alterations in the proximal part of the femur, especially at the greater trochanter, and the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of available information.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery performed due to radiolucency 5 years and 4 months after the primary.The stem has been replaced with a bigger size (amistem-p), the head as well.The head was not a medacta product.

• Brand Name: STEM: AMISTEM H HA COATED LAT 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: 9932110
• Report Number: 3005180920-2020-00221
• Device Sequence Number: 14110543
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 141478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/07/2020
• 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
• Patient Age: 84 YR