MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H 01.12.025 CEMENTLESS, HA COATED STD STEM SIZE 5; HIP CEMENTLESS STEM

Catalog Number 01.12.025

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

No device info available for now.If more info will become available a fu communication will be performed.

Event Description

At 1 year and 11 months after the primary surgery, the surgeon revised the stem, head and liner due to stem mobilization.The exact primary date is unknown.

Event Description

At 2 years after the primary surgery, the surgeon revised the stem, head, and liner due to stem mobilization.

Manufacturer Narrative

Batch review performed on 09 february 2022: lot 1902331: 60 items manufactured and released on 12-july-2019.Expiration date: 2024-07-01.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event.Visual inspection performed by r&d manager: during the analysis it is evaluated that all the ha on the stem body has been completely absorbed by patient bone as expected.A lot of signs and scratches are present on the neck part of the stem probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening.

• Brand Name: QUADRA-H 01.12.025 CEMENTLESS, HA COATED STD STEM SIZE 5
• 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: 13024861
• MDR Text Key: 282399521
• Report Number: 3005180920-2021-00978
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 03/07/2022

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 Catalogue Number: 01.12.025
• Device Lot Number: 1902331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• 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: 70 YR
• Patient Sex: Male