MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-P STD STEM SIZE 3; HIP CEMENTLESS STEM

Catalog Number	01.12.123
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 11 months after the primary, the patient was revised because of infection caused by staphylococcus capitis.The infection led to stem subsidence.All the implants have been removed successfully.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible as the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.If any further information is provided, the investigation report will be updated.

• Brand Name: QUADRA-P STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS STEM
• 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: 17649039
• Report Number: 3005180920-2023-00654
• Device Sequence Number: 7371263
• Product Code: LZO
• UDI-Device Identifier: 07630040720441
• UDI-Public: 07630040720441
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 08/30/2023

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 Expiration Date: 02/07/2026
• Device Catalogue Number: 01.12.123
• Device Lot Number: 2011473
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2021
• 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: 59 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White