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

Model Number	01.12.022
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 october 2020: lot 091043: (b)(4) items manufactured and released on 04-june-2009.Expiration date: 2014-04-30.No anomalies found related to the problem.To date all items of the same lot have been already sold without any similar reported event since 01-jan-2016.Clinical evaluation performed by medical affairs director: hip revision surgery performed 10 years after cementless total hip arthroplasty in a (b)(6) year old woman.According to the report, the reason of stem removal is impingement with the acetabular component.Radiographic images provided show the presence of suboptimal acetabular component position.We cannot tell if this was the initial position or the result of cup migration.This has probably caused abnormal wear of the acetabular insert that resulted in extensive osteolytic damage to the femoral bone, causing loosening of the stem.The reason of stem removal is hardly related to an implant malfunction.
Event or Problem Description
Revision surgery 9 years and 11 months after primary surgery for impingement of medacta devices with the acetabular shell of competitor.The surgeon revised successfully the medacta stem and head.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMETLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10725241
• Report Number: 3005180920-2020-00725
• Device Sequence Number: 19669396
• 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: 2010
• 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): 10/23/2020

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: 04/30/2014
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 091043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: 65 YR