MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H CEMENTLESS STEM; FEMORAL CEMENTLESS STEM

Catalog Number	01.12.025
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director made the following analysis: partial hip revision surgery (stem and head) occurred 3 years after primary total hip arthroplasty.Radiographic image provided shows the presence of signs of stress-shielding and very significant bone remodeling.It should be assumed that the hypothesis of an infection has been properly ruled out byt he surgical team, although the femur looks, in the short and poor quality radiograph supplied, rather peculiar.The reason of this event cannot be determined with the information at hand.Batch review performed on (b)(6) 2018: lot 145665: 40 items manufactured and released on (b)(6) 2014.Expiration date: (b)(6) 2019.No anomalies found related to the issue.To date, 39 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Three years after primary the surgeon detected a stem loosening and revised the patient.The revision surgery was completed successfully.

• Brand Name: QUADRA H CEMENTLESS STEM
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163362
• Report Number: 3005180920-2017-00813
• Device Sequence Number: 63245
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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: 09/30/2019
• Device Catalogue Number: 01.12.025
• Device Lot Number: 145665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 64