MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; HIP UNCEMENTED STEM

Model Number	01.12.026
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 113241: (b)(4) items manufactured and released on 21-dec-2011.Expiration date: 2016-11-30.No anomalies found related to the problem.2 items resterilized and released on 15-may-2013.Expiration date: 2018-03-31.No anomalies found related to the problem.1 item resterilized and released on 01-sep-2016.Expiration date: 2021-08-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Preliminary investigation performed on the (b)(6) 2020 by medacta hip r&d project manager: implant covered in bio-fluids.Ha layers disappeared during time in-situ.Clinical evaluation performed by medacta medical affairs director: 8 years after primary cementless tha the stem is removed because loosening is suspected.The images supplied do not allow a proper evaluation of the radiological situation pre-revision.Radiolucency seems to be present, but causes for loosening cannot be determined with the information at hand.
Event or Problem Description
Revision surgery was performed 8 years after primary on a patient with suspected loosening of quadra h implant.X-rays showed radiolucent lines.No signs of infection.Stem and head were revised.Stem was easy to remove.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10161543
• Report Number: 3005180920-2020-00342
• Device Sequence Number: 11426449
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• 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: 2012
• 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): 06/17/2020

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: 11/30/2016
• Device Model Number: 01.12.026
• Device Catalogue Number: 01.12.026
• Device Lot Number: 113241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/17/2020
• 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
• Patient Age: 80 YR
• Patient Weight: 90