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

Model Number	01.12.025
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 july 2021: lot 083652: (b)(4) items manufactured and released on 05-feb-2009.Expiration date: 31/12/2013.No anomalies found related to the problem.To date, all items of the same lot have been sold.No other similar events have been reported on this lot since 2017.Clinical evaluation performed by medical affairs manager: hip revision surgery performed 12 years after cementless tha in (b)(6) year old man.Radiologic image provided shows the presence of bone alterations that can be ascribed to an infection.Infection is a known possible adverse event following every surgery, including tha's and can be hardly related to implant.Preliminary investigation performed by project manager: looking at the picture received with the complaint is possible to see the hydroxyapatite has been totally reabsorbed as expected.No definitive root cause can be defined.
Event or Problem Description
Revision surgery performed 12 years 2 months after the primary due to stem loosening with supposed infection.The surgeon decided to remove all the implants and implant a new hip.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12223761
• Report Number: 3005180920-2021-00645
• Device Sequence Number: 19943585
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 12/31/2013
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 083652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/26/2021
• 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: 83 YR
• Patient Weight: 46