MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; STEM: QUADRA-H 01.12.024 CEMENTLESS, HA COATED STD STEM SIZE 4

Model Number	01.12.024
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21-jan-2025: lot 146839: (b)(4) items manufactured and released on 23-jan-2015.Expiration date: 21-dec-2019.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Other device involved: cup: versafitcup cc trio 01.26.45.0056 acetabular shell cc trio ø 56 (k103352) lot 147726: (b)(4) items manufactured and released on 25-feb-2015.Expiration date: 31-jan-2020.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 9 years 9 months after primary, the patient has been revised because of acetabular shell and cementless stem loosening.The surgeon revised successfully all the components.
Additional Manufacturer Narrative
Analysis performed by r&d manager: from the images attached to the complaint the following explanted implants are visible: -stem: in the images the proximal half of the explanted stem is visible, the stem is covered with patient blood and the stem is free of ha coating.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.-cup and liner: in the images the explanted shell connected with the liner are visible; the external surface of the shell and the internal part of the liner are covered with patient blood residuals.Both on the liner some signs of minor damage and scratches are present which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the cup loosening reported.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: STEM: QUADRA-H 01.12.024 CEMENTLESS, HA COATED STD STEM SIZE 4
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21364654
• Report Number: 3005180920-2025-00045
• Device Sequence Number: 20973265
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 12/21/2019
• Device Model Number: 01.12.024
• Device Lot Number: 146839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White