MAUDE Adverse Event Report: Medacta International SA Quadra P femoral stems; Quadra-P Std. size3

Model Number	01.12.123
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 12 days after the primary surgery, revision surgery was performed due to infection.The initial indication for revision was instability; however, intraoperatively, an infection was identified, resulting in the removal of all implants.All implants were successfully removed.
Additional Manufacturer Narrative
Batch review performed on 31 august 2026 stem: quadra-p 01.12.123 quadra-p std.Size 3 (k181254) lot.2528214: 120 items manufactured and released on 11-march-2026.Expiration date: 2031-02-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Cup: mpact 01.32.148dht acetabular shell d 48 two-holes t (k230011) lot.2602080: (b)(4) items manufactured and released on 07-april-2026.Expiration date: 2031-03-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Ball heads: cocr 01.25.021 cocr ball head 12/14 d 32 size s -3.5 (k072857) lot.2502580: (b)(4) items manufactured and released on 26-may-2025.Expiration date: 2030-05-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.3241hcat hooded pe hc liner d 32/d (k132879) lot.2302198: 18 items manufactured and released on 22-march-2023.Expiration date: 2028-03-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Screws: mpact 01.43.0030 cancellous bone screw d 6,5 l30 (k200391) lot.2413339: 80 items manufactured and released on 17-june-2024.Expiration date: 2029-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Screws: mpact 01.43.0025 cancellous bone screw d 6,5 l25 (k200391) lot.2519445: (b)(4) items manufactured and released on 16-february-2026.Expiration date: 2031-01-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events 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.

• Brand Name: Quadra P femoral stems
• Common Device Name: Quadra-P Std. size3
• 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: 50692283
• Report Number: 3005180920-2026-00930
• Device Sequence Number: 9684530
• Product Code: LZO
• UDI-Device Identifier: 07630040720441
• UDI-Public: 07630040720441
• Combination Product (Y/N): N
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 01.12.123
• Device Lot Number: 2528214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2026
• 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: Female
• Patient Weight: 308 LB
• Patient Race: White