MAUDE Adverse Event Report: Medacta International SA Quadra H femoral stems; QUADRA "H" Short neck, cem.less, lat, HAP S. 5

Model Number	01.12.35SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Implant Pain (4561); Aseptic loosening (4883)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury

• Brand Name: Quadra H femoral stems
• Common Device Name: QUADRA "H" Short neck, cem.less, lat, HAP S. 5
• 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: 50543230
• Report Number: 3005180920-2026-00865
• Device Sequence Number: 10588222
• Product Code: LZO
• UDI-Device Identifier: 07630030802751
• UDI-Public: 07630030802751
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/01/2026

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: 01.12.35SN
• Device Lot Number: 170888B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 209 LB
• Patient Race: White