MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA R FEMORAL STEMS; QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 6

Model Number	01.12.066
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 march 2025.Stem: quadra -r 01.12.066 quadra r - stem cement-less hap 12/14 s.6 lot 2112945 (k082792 and k250450): (b)(4) items manufactured and released on 09-feb-2022.Expiration date: 2027-jan-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Ball heads: mectacer 01.29.210 mectacer head biolox delta dia.36 12/14-l lot.2319276 (k112115): (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 2028-aug-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Cup: mpact 01.32.160dh acetabular shell d 60 two-hole lot.2208229 (k132879 and k250450): (b)(4) items manufactured and released on 02-sep-2022.Expiration date: 2027-aug-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact 01.32.3652hct mpact flat liner hc 36/g lot.2009615 (k103721): (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-oct-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Revision surgery due to infection 1year and 10 months month after the first revision surgery.The patient had primary surgery using competitor products.On (b)(6) 2024, the patient was revised to medacta implants.Presently, on (b)(6) 2026, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all implants to address the infection.The surgery was completed successfully.

• Brand Name: QUADRA R FEMORAL STEMS
• Common Device Name: QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 6
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24711327
• Report Number: 3005180920-2026-00251
• Device Sequence Number: 17555777
• Product Code: JDI
• UDI-Device Identifier: 07630030802447
• UDI-Public: 07630030802447
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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 Model Number: 01.12.066
• Device Lot Number: 2112945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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 Sex: Male