MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-CEMENTLESS HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.12.031
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 26 january 2018 by medical affairs: partial hip revision surgery occurred 1 year and 2 months after primary cementless tha in a (b)(4) year-old patient.Radiographic images provided show the presence of signs of stress shielding suggesting insufficient proximal fixation.Aseptic loosening is a possible, literature described adverse event after cementless tha and reasons are often unknown.The cause of this failure cannot be determined.Batch review performed on 30 january 2018 lot 157366: (b)(4) items manufactured and released on 11 april 2016.Expiration date:2021-03-30 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed on 02 february 2018 by r&d product manager based on the pictures received: the received photos were analyzed.The stem did not show any particular sign of failure, only some scratches are visible due to revision surgery.Also, blood covered most of the surfaces as the photos were taken just after the explant.From the received images it cannot be possible to determine the root cause of the event.
Event or Problem Description
One year and 1 month after primary the patient was revised for a stem loosening.The stem was swapped successfully.

• Brand Name: QUADRA-CEMENTLESS HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7237241
• Report Number: 3005180920-2018-00011
• Device Sequence Number: 11020055
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: 03/30/2021
• Device Catalogue Number: 01.12.031
• Device Lot Number: 157366
• 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: 01/03/2018
• Initial Report FDA Received Date: 02/02/2018
• 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: 67 YR