FDA Adverse Event Injury Summary report: N

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2

MDR report key: 7909554 · Received September 26, 2018

Report

Report Number: 3005180920-2018-00721
Event Type: Injury
Date Received: September 26, 2018
Date of Event: August 27, 2018
Report Date: September 26, 2018
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JDI
UDI-DI: 07630030802034
PMA / PMN Number: K082792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 24 SEPTEMBER 2018. LOT 132352: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 SEPTEMBER 2013, EXPIRATION DATE: 2018-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED ON 31 AUGUST 2018 BY R&D PRODUCT MANAGER: FROM PRELIMINARY INVESTIGATION, NO PARTICULAR SIGNS CAN BE HIGHLIGHTED. HYDROXYAPATITE LAYER SEEMS ABSORBED DURING IMPLANTATION TIME, HOWEVER, NO BONE RESIDUAL IS VISIBLE ON THE STEM AFTER EXTRACTION, WHICH IS IN LINE WITH THE LOOSENING DIAGNOSIS. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 24 SEPTEMBER 2018: NO PARTICULAR SIGNS CAN BE HIGHLIGHTED. HYDROXYAPATITE LAYER SEEMS ABSORBED DURING IMPLANTATION TIME, HOWEVER, NO BONE RESIDUAL IS VISIBLE ON THE STEM AFTER EXTRACTION, WHICH IS IN LINE WITH THE LOOSENING DIAGNOSIS. VISUAL INVESTIGATION IN LINE WITH IMAGE PRELIMINARY INVESTIGATION.

Description of Event or Problem · 1

THE PATIENT HAD A LOOSE STEM THAT NEEDED TO BE REVISED. THE STEM WAS REMOVED AND A QUADRA C WAS IMPLANTED 4 YEARS AFTER THE PRIMARY SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
750156	QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2	CEMENTLESS HIP STEM	JDI	MEDACTA INTERNATIONAL SA		132352	07630030802034

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention