MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.24SN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 november 2019.Lot 156134: 25 items manufactured and released on 06-apr-2016.Expiration date: 2021-03-23.No anomalies found related to the problem.To date, 30 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director.3 years after primary cementless dm tha a significant subsidence of the stem is recorded.We have no evidence of the postoperative situation nor do we know when the subsidence supposedly occurred.A late subsidence of this dimension, in absence of traumas, fractures, pathological situations is extremely rare and to us inexplicable.With the information at hand, we are unable to offer a cause for the event.
Event or Problem Description
The patient came in, 2.5 years after primary surgery, complaining of instability due to a subsided stem.The cause of the subsided stem is unknown.The surgeon revised the stem, head, and liner and the surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9393526
• Report Number: 3005180920-2019-01007
• Device Sequence Number: 19510022
• Product Code: LZO
• UDI-Device Identifier: 07630030802645
• UDI-Public: 07630030802645
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 03/23/2021
• Device Catalogue Number: 01.12.24SN
• Device Lot Number: 156134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 12/02/2019
• 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