MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; UNCEMENTED HIP STEM

Model Number 01.12.024

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12.03.2021: lot 052090: (b)(4) items manufactured and released on 31-mar-2006.Expiration date: 2011-02-28.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.Preliminary investigation performed by medacta r&d project manager: looking at the image attached to the complaint is visible that the whole ha coating on the stem body has been absorbed by patient bone as expected.No particular signs or damages are present on the explanted stem.It is not possible to define a root cause of the reported loosening.Clinical evaluation performed by medacta medical affairs director: femoral component revision performed about 14,5 years after primary cementless total hip arthroplasty in a (b)(6) year old man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, signs of osteolysis and stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.Of course the probability that a total hips involved in phenomena of stress shielding and osteolysis is bound to increase with time and activity, as specified in the instructions for use.The exact reason of this event cannot be determined.

Event Description

Loosening of a quadra-h (4 std) stem after 14 years and 7 months after the primary surgery.The surgeon revised the stem, head and inlay.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Type of Device: UNCEMENTED HIP 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: 11593997
• MDR Text Key: 243106164
• Report Number: 3005180920-2021-00251
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 052090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2006
• 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: 58 YR