MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-S 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3; FEMORAL COMPONENT

Model Number	01.12.023
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 july 2021: (b)(4) items manufactured and released on 18-aug-2009.Expiration date: 2014-june-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Other devices involved: batch review performed on 29 july 2021: versafitcup dm 01.26.2852m double mobility liner diam 52/28 (k083116) lot.092006: (b)(4) items manufactured and released on 14-sep-2009.Expiration date: 2014-july-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
The patient came in for a post-op appointment and the x-rays revealed that there osteolysis around the femur.The cause of the osteolysis is unknown.11 years and 6 months after the primary surgery, the surgeon put bone graft around the femur and revised the head and liner.The surgery was completed successfully.

• Brand Name: QUADRA-S 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12364714
• Report Number: 3005180920-2021-00673
• Device Sequence Number: 3974198
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 06/30/2014
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 091592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/25/2021
• 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