MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 LOT. 102677; CEMENTLESS HIP STEM

Catalog Number	01.12.020
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 april 2018.Lot 102677: (b)(4) items manufactured and released on 18 october 2010.Expiration date: 2015-09-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Other implant involved is versafitcup cc trio 01.26.45.0048 (k103352) acetabular shell cc trio ø 48.Lot 130558: (b)(4) items manufactured and released on 05 april 2013.Expiration date: 2018-02-28 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.Clinical evaluation performed on 25 april 2018 by medical affairs director: five years after primary cementless tha a total revision is required.The stem is mobilized and the cup needs repositioning.The stem looks undersized and cup inclination suboptimal.The postoperative history is not known.We may suppose that undersized and positioning may have played a role in the setting of the event, but we must also consider that the devices remained in situ for 5 years.The conclusion on the causes of the incident can therefore not be final, but there is no apparent reason to suspect a faulty device.
Event or Problem Description
On (b)(6) 2018 medacta's customer service has been informed about a revision hip surgery, reason for revision unknown.Revision surgery booked (b)(6) 2018.Post revision information received by mail by sales representative on the (b)(4) 2018: the patient complained long term pain.Diagnosis from surgeon is aseptic loosening of femoral component.Acetabular malpositioning.Anterior wall deficit.Revision was completed (b)(6) 2018.Stem grossly loose, removed by hand with burnishing of distal tip.Acetabular component removed.Cup positioned with anterior wall defect at index surgery.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0 LOT. 102677
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7463814
• Report Number: 3005180920-2018-00274
• Device Sequence Number: 13478943
• Product Code: JDI
• UDI-Device Identifier: 07630030802010
• UDI-Public: 07630030802010
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 09/30/2015
• Device Catalogue Number: 01.12.020
• Device Lot Number: 102677
• 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: 03/28/2018
• Initial Report FDA Received Date: 04/26/2018
• 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: 54 YR
• Patient Weight: 69