MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; CEMENTLESS STEM

Model Number	01.12.023
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 06.04.2021: lot 113031: (b)(4) items manufactured and released on 20-dec-2011.Expiration date: 2016-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events since 2017.Clinical evaluation performed by medical affairs manager: femoral component (stem, head and liner) revision performed 9 years after primary cementless total hip arthroplasty in a (b)(6) year old, heavy ((b)(6) kg) man.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 adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by r&d project manager: looking at the image to the complaint it is visible that the whole ha coating has been absorbed by patient bone as expected.No particular signs of scratches or damages are present on the expianted stem.It is not possible to determine the root cause of the reported loosening.
Event or Problem Description
Revision surgery performed 9 years and 2 months after the primary surgery due to stem mobilization.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11626622
• Report Number: 3005180920-2021-00264
• Device Sequence Number: 3499250
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: 2012
• 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): 04/07/2021

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: 09/30/2016
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 113031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/07/2021
• 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: 72 YR
• Patient Weight: 103