MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GUDID BRAND NAME; QUADRA P FEMORAL STEMS

Model Number	01.12.126
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2024.Lot: 2116227: (b)(4) items manufactured and released on 30-march-2022.Expiration date: 2027-03-08.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.Clinical evaluation performed by medical affairs department a revision surgery was performed following others previous revision surgeries in a case of total hip artrthroplasty.The reason for this latest revision was an infection.The available x-ray images reveal stem loosening, with a previously occurred fracture of the greater trochanter not completely healed, as well as signs of bone remodeling/calcification around the lesser trochanter.Infection is a known possible adverse event following any surgery, including tha, particularly in case of multiple revisions.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional implants revised.Batch review performed on 11 november 2024 on ball heads: mectacer 01.29.210 mectacer head biolox delta dia.36 12/14-l (k112115) lot: 2319276, lot: 2319276: (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 2028-08-16.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.Batch review performed on 11 november 2024 on cup: versafitcup cc trio 01.26.45.1154 acetabular shell cc trio no-hole ø 54 (k122911) lot: 2006339, lot: 2006339: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-09-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Batch review performed on 11 november 2024 on liner: versafitcup cc trio 01.26.3644hct flat pe hc liner ø36/e (k120531) lot: 2009641, lot: 2009641: (b)(4) items manufactured and released on 25-nov-2020.Expiration date: 2025-11-11.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.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
On (b)(6) 2021, the patient had primary hip surgery.On (b)(6) 2021, revision surgery for joint luxation.Head and liner revised.On (b)(6) 2024, the patient had pain and femur aseptic loosening due to a traumatic event.The surgeon revised stem and head.On (b)(6) 2024, explantation of all components due to infection (staph aureus).

• Brand Name: GUDID BRAND NAME
• Common Device Name: QUADRA P FEMORAL STEMS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20757905
• Report Number: 3005180920-2024-00991
• Device Sequence Number: 9493760
• Product Code: LZO
• UDI-Device Identifier: 07630040720472
• UDI-Public: 07630040720472
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 01.12.126
• Device Lot Number: 2116227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2022
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White