MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM

Model Number	01.12.022
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 3 july 2020: lot 174392: (b)(4) items manufactured and released on 28-nov-2017.Expiration date: 2022-11-19.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.Clinical evaluation performed by medical affairs manager: revision surgery performed 1 year and 3 months after primary cementless total hip arthroplasty.No information concerning patient age, weight and general health status is available.In the radiographic images provided, the stem looks subsided probably due slightly undersizing.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.The reason of this failure cannot be determined.
Event or Problem Description
1 year and 3 months after the primary surgery the surgeon had planned to remove the femoral stem that had subsided due to what he suspected was undersizing of the implant.After 2 hours of trying to remove the stem he was unable to remove the well fixed stem so it was left in situ and subsequently he changed the femoral head from a 36mm +0 to a 36mm +7.The surgeon confirmed that the stem was subsided but is not sure if the reason is undersized stem.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10300533
• Report Number: 3005180920-2020-00448
• Device Sequence Number: 16272361
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2019
• 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): 07/21/2020

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: 11/19/2022
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 174392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/21/2020
• 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