MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; CEMENTLESS HIP STEM

Model Number	01.12.026
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 february 2021: lot 092594: (b)(4) items manufactured and released on 19-jan-2010.Expiration date: 2014-11-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since 1-jan-2017.Preliminary investigation performed by r&d project manager: looking at the images it is visible that the ha coating on the stem body has been completely absorbed.Slight signs of scratches are present on the neck area.The reason of this failure cannot be determined.Clinical evaluation performed by medical affairs manager: hip revision performed 8 years and 9 months after cementless total hip arthroplasty in (b)(6) year old woman.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.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 8 years and 10 months after primary for suspected loosening.During the revision the stem came out easily.No infection detected.The surgery was completed successfully, stem, head and liner revised successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11371319
• Report Number: 3005180920-2021-00147
• Device Sequence Number: 14462408
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 11/30/2014
• Device Model Number: 01.12.026
• Device Catalogue Number: 01.12.026
• Device Lot Number: 092594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: 66 YR
• Patient Weight: 90