MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA "H" SHORT NECK, CEM.LESS, STD, S.00

Model Number	01.12.98SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 june 2026 stem: quadra-h 01.12.98sn quadra & quot; h & quot; short neck, cem.Less, std, s.00 (k121011) lot: 2107742: (b)(4) items manufactured and released on 09-nov-2021.Expiration date: 26-oct-2026.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.Clinical evaluation four years after a primary cementless tha in an overweight female patient, the entire hip construct was revised following reports of persistent pain over the preceding year.The stem was clearly loose proximally; however, insufficient information is available to determine why the acetabular component was revised as well.The stem also appears relatively small (not necessarily undersized, but small), and it is unknown whether the patient & size 39; s body mass index changed significantly since 2022.There is no reason to suspect that this adverse event was caused by a defect or malfunction of the implanted devices.Failure of osseointegration, or more likely loss of osseointegration, is well documented in the literature and is commonly classified as aseptic loosening.Root cause: based on the information available, no definitive root cause can be established.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
Primary hip surgery was performed on (b)(6) 2022.Approximately one year before the revision surgery, the patient reported the onset of mid-thigh pain and initially consulted their local doctor, receiving pain management and physiotherapy before being reviewed by an orthopaedic consultant.During the clinical investigation, the revision surgeon noted proximal loosening on x-ray, referring to the femoral stem.Based on these findings, the surgeon decided to remove the stem and change the cup size, as the patient was considered to be at increased risk of dislocation due to obesity.Revision surgery was performed on (b)(6) 2026, during which all implants were replaced with competitor devices according to the surgeon`s preference, with implantation of a size 50 competitor dual mobility cup.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA "H" SHORT NECK, CEM.LESS, STD, S.00
• 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: 25714731
• Report Number: 3005180920-2026-00610
• Device Sequence Number: 14738006
• Product Code: LZO
• UDI-Device Identifier: 07630030802935
• UDI-Public: 07630030802935
• Combination Product (Y/N): N
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/06/2026

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: 01.12.98SN
• Device Lot Number: 2107742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Race: White