MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM

Model Number	01.12.035
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 september 2018: lot 124806: 25 items manufactured and released on 4 february 2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on sep 4, 2018: hip revision surgery (stem, head and liner) occurred 5 years and 5 months after primary cementless total hip arthroplasty.Poor quality of radiographic images provided doesn't allow a proper clinical evaluation.Aseptic loosening is a possible literature described mid term adverse event after cementless total hip replacements and causes are often unknown.The cause of this event cannot be determined on the basis of information received.
Event or Problem Description
On aug 20, 2018 we were informed that the patient needed a revision surgery due to loosening of femur prosthesis detected through bone scan 5 years and 5 months after primary; radiolucent lines were found around the distal portion of the stem.Patient had pain.On (b)(6) 2018 the surgeon revised the mpact flat pe hc liner 36/f (01.32.3648hct), quadra lat s5 stem (01.12.035) and 36m ceramic head (38.49.7179.285.00) with zimmer revision stem and head.The surgeon changed the liner to have a total new bearing surface and articulation.Case was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7888914
• Report Number: 3005180920-2018-00693
• Device Sequence Number: 2508219
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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: 12/31/2017
• Device Model Number: 01.12.035
• Device Lot Number: 124806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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: 61 YR