MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; HIP UNCEMENTED STEM

Model Number	01.12.023
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 may 2020: lot 130616: (b)(4) items manufactured and released on 24-apr-2013.Expiration date: 2018-03-31.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 since 2016.Clinical evaluation performed by medacta medical affairs director: 7 years after primary cementless tha the stem is deemed to be loose and replaced, along with head and liner as customary.Only one frontal xray is supplied, and it is not sufficient to draw any reliable conclusion as to the causes of revision.A thin radiolucent line is visible around the stem, but causes cannot be determined.Secondary loosening is a possible adverse event following tha, described in literature, and causes are often unknown.
Event or Problem Description
Revision surgery performed, 6 years and 10 months after primary surgery, due to stem loosening.Femoral components and liner were successfully revised.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10147518
• Report Number: 3005180920-2020-00331
• Device Sequence Number: 2094382
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 03/31/2018
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 130616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/12/2020
• 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