MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; HIP CEMENTLESS STEM

Model Number	01.12.023
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 october 2020: lot 124320: (b)(4) items manufactured and released on 11-jan-2013.Expiration date: 2017-11-30.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 since 2016.Preliminary investigation performed on 30 october 2020 by medacta hip project manager: from the photos it appeared that the stem was totally without ha coating, which was completely absorbed, index of a good osseo-integration; moreover, bone and blood were present in the distal and diaphyseal part of the stem.From the received photos it was not possible to determine the root cause of the event.Clinical evaluation performed on 30 october 2020 by medacta medical affairs manager: femoral component revision surgery performed 7 years and 7 months after primary cementless total hip arthroplasty in a (b)(6) year old, heavy ((b)(6) kg) woman.Radiographic images provided show the presence of a subsided stem.This may be due to a slight stem undersizing.The reason of this choice cannot be assessed not having preoperative images.Patient weight may also have contributed to this event.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery performed after 7 years and 7 months due to subsidence of stem.The stem and head were revised and a competitor stem was cemented in.There was considerable difficulty removing the size 3 standard offset quadra stem that required an eto (extended trochanteric osteotomy) and subsequent cables.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10867719
• Report Number: 3005180920-2020-00817
• Device Sequence Number: 2521749
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: 2013
• Device Explanted Year: 2020
• 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): 11/19/2020

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: 11/30/2017
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 124320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/19/2020
• 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: 68 YR
• Patient Weight: 110