MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P CEMENTED STD STEM SIZE1

Model Number	01.12.211
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 feb 2026 lot 2348635: (b)(4) items manufactured and released on 09 apr 2024.Expiration date: 14 mar 2029.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.Lot 2419271: (b)(4) items manufactured and released on 15 jul 2024.Expiration date: 01 jul 2029.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.Lot 2410941: (b)(4) items manufactured and released on 28 may 2024.Expiration date: 12 may 2029.One anomaly was recorded; however, it was not related to the problem under review.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 was performed 1 year and 2 months after the primary procedure due to infection.The pathogen was unknown.The surgery was completed successfully.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P CEMENTED STD STEM SIZE1
• 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: 24429839
• Report Number: 3005180920-2026-00143
• Device Sequence Number: 10297506
• Product Code: LZO
• UDI-Device Identifier: 07630040732086
• UDI-Public: 07630040732086
• Combination Product (Y/N): N
• PMA/510(K) Number: K192827
• 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): 02/24/2026

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: 01.12.211
• Device Lot Number: 2348635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White