MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED HA COATED STD SIZE 5; UNCEMENTED HIP STEM

Model Number	01.18.235
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07.February.2020: lot 146260: (b)(4) items manufactured and released on 21-nov-2014.Expiration date: 2019-10-30.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 medacta medical affairs director: femoral component revision surgery performed 4 years after cementless total hip arthroplasty.No information concerning patient age, gender, activity level and health status is available.Radiographic image provided shows the presence of signs of stress shielding suggesting distal fixation of the stem.Aseptic loosening is a possible literature described adverse event after 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 5 years and 2 months from the primary due to potted stem.The cause of the potted stem is unknown.The surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED HA COATED STD SIZE 5
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9762414
• Report Number: 3005180920-2020-00095
• Device Sequence Number: 11376775
• Product Code: LZO
• UDI-Device Identifier: 07630030804601
• UDI-Public: 07630030804601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 02/27/2020

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: 10/30/2019
• Device Model Number: 01.18.235
• Device Catalogue Number: 01.18.235
• Device Lot Number: 146260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/27/2020
• 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