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

Model Number 01.12.032

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 04 december 2020: lot: 072508: 44 items manufactured and released on 30-oct-2007.Expiration date: 2012-09-30.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.Clinical evaluation performed by medacta medical affairs manager: femoral component (stem, head and liner) revision performed 11 years and 10 months after primary cementless total hip arthroplasty in 72 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 long-term adverse event after primary cementless hip arthroplasties, and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by medacta r&d hip project manager: from the received photos there are no suspects of failure device, as no particular signs on the device were noticed.Anyway, the reason of the event remains unknown.

Event Description

Loosening of a quadra-h stem implanted in 2009.Stem, head and liner have been successfully revised (11 years and 10 months after primary surgery).Revision was done with a minimax.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 2
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11045454
• MDR Text Key: 223718933
• Report Number: 3005180920-2020-00908
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 072508
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88