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

Catalog Number	01.12.033
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-november-2019: lot 061366: 38 items manufactured and released on 18-october-2006.Expiration date: 2011-september-30.No anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 13 years after primary cemetless total hip arthroplasty in a (b)(6) man.The image provided doesn't allow a complete evaluation of the implant-bone interface: however, radiolucent lines are visible suggesting implant mobilization.No information concerning patient general health status is available.Aseptic loosening is a possible, literature described, long term adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed, after 13 years from the primary surgery, due to stem loosening.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE 3
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9383327
• Report Number: 3005180920-2019-00990
• Device Sequence Number: 2514531
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• 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: 2006
• 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): 11/27/2019

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: 09/30/2011
• Device Catalogue Number: 01.12.033
• Device Lot Number: 061366
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/27/2019
• 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
• Patient Age: 75 YR