MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS SIZE 2; HIP STEM CEMENTLESS

Catalog Number	01.12.032
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: femoral component revision occurred 5 years and 3 months after cementless total hip arthroplasty.No information concerning patient age and general health status is available.Radiographic image provided shows pronounced stem subsidence, which has probably contributed to stress shielding.Subsidence may be due to insufficient bone quality or insufficient press fit achieved at the time of primary implantation: we do not know when the subsidence occurred, certainly not recently.In this case, initial implant position and femoral bone morphology cannot be assessed not having immediate post-surgery and preop x-rays.Batch review performed on 16 april 2019: lot 124802: (b)(4) items manufactured and released on 21-feb-2013.Expiration date: 2018-01-31.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.
Event or Problem Description
On (b)(6) we were informed about a revision surgery planned on (b)(6).About 5 years and 3 months after primary the surgeon revised the patient for stem subsidence.Stem and ceramic head swapped successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS SIZE 2
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8527536
• Report Number: 3005180920-2019-00284
• Device Sequence Number: 1885220
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 01/31/2018
• Device Catalogue Number: 01.12.032
• Device Lot Number: 124802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/18/2019
• 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