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

Model Number 01.12.022

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 24 august 2021: lot 166213: (b)(4) items manufactured and released on 05-jan-2017.Expiration date: 2021-dec-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs department: stem revision performed 4 years after primary cementless total hip arthroplasty in a young man ((b)(6) year old at time of primary surgery).No information concerning patient's level of activity, general health status or 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 Description

Revision of a quadra h due to loosening, pain.The cause of loosening is not known.Head and stem were revised 4 years after the primary surgery.

Manufacturer Narrative

Visual inspection: during the analysis it is evaluated that on the proximal part of the stem (around one third of the overall length) is covered with residual ha.This is really unexpected because the stem is implanted "since" 2017 meaning that the stem was not correctly osteointegrated with the patient bone causing the loosening.Some sings and scratches are present on the stem neck due to the revision surgery.The "root" cause of the reported loosening is the lack of osteointegration of the stem while it is not possible to clinically determine its cause.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 2
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12479677
• MDR Text Key: 271634541
• Report Number: 3005180920-2021-00743
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (y/n): N
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 166213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 90