FDA Adverse Event Injury Summary report: N

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK

MDR report key: 11504350 · Received March 17, 2021

Report

Report Number: 3005180920-2021-00223
Event Type: Injury
Date Received: March 17, 2021
Date of Event: February 22, 2021
Report Date: March 17, 2021
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JDI
UDI-DI: 07630030802621
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 26.02.2021: LOT 1904451: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-SEP-2019. EXPIRATION DATE: 2025-10-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 3 MONTHS AFTER CMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN. NO INFORMATION CONCERNING PATIENT ACTIVITY, GENERAL HEALTH STATUS AND PRESENCE OF COMORBIDITIES. RADIOGRAPHIC IMAGES PROVIDED SHOW STEM SUBSIDENCE AND LEG LENGTH DISCREPANCY. THE STEM LOOKS SLIGHTLY UNDERSIZED: THE REASON OF THIS CHOICE CANNOT BE ASSESSED ON THE BASIS OF INFORMATION RECEIVED. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

3 MONTHS AFTER THE PRIMARY SURGERY THE STEM SUBSIDED AND IT SHOULD HAVE BEEN REVISED BUT THE SURGEON COULD NOT EXTRACT IT EVEN AFTER CONSIDERABLE EFFORT. THE STEM REMAINED IN SITU AND A BIGGER HEAD WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
397822	QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK	HIP CEMENTLESS STEM	JDI	MEDACTA INTERNATIONAL SA	01.12.22SN	1904451	07630030802621

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention