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

Catalog Number	01.12.022
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018.Lot 132352: (b)(4) items manufactured and released on 04 september 2013, expiration date: 2018-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed on 31 august 2018 by r&d product manager: from preliminary investigation, no particular signs can be highlighted.Hydroxyapatite layer seems absorbed during implantation time, however, no bone residual is visible on the stem after extraction, which is in line with the loosening diagnosis.Visual inspection performed by r&d product manager on 24 september 2018: no particular signs can be highlighted.Hydroxyapatite layer seems absorbed during implantation time, however, no bone residual is visible on the stem after extraction, which is in line with the loosening diagnosis.Visual investigation in line with image preliminary investigation.
Event or Problem Description
The patient had a loose stem that needed to be revised.The stem was removed and a quadra c was implanted 4 years after the primary surgery.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7909554
• Report Number: 3005180920-2018-00721
• Device Sequence Number: 1936611
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: 09/04/2013
• Device Catalogue Number: 01.12.022
• Device Lot Number: 132352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/26/2018
• 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: 70 YR
• Patient Weight: 94