FDA Adverse Event Injury Summary report: N

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK

MDR report key: 7536826 · Received May 23, 2018

Report

Report Number: 3005180920-2018-00350
Event Type: Injury
Date Received: May 23, 2018
Date of Event: April 23, 2018
Report Date: May 23, 2018
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030802652
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 22 MAY 2018. LOT 166565: 30 ITEMS MANUFACTURED AND RELEASED ON 13 FEBRUARY 2017. EXPIRATION DATE: 2022-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHERS DEVICES INVOLVED: MPACT DM DOUBLE MOBILITY HC LINER Ø 52/28 REFERENCE 01.26.2852MHC (K092265). LOT 177528: 110 ITEMS MANUFACTURED AND RELEASED ON 20 FEBRUARY 2018. EXPIRATION DATE: 2023-02-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 56 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52 REFERENCE 01.32.152MB (K143453). LOT 176647: 39 ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2018 EXPIRATION DATE: 2023-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

THREE DAYS AFTER PRIMARY THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER FOR A HIP DISLOCATION AND FEMUR FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
378512	QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK	CEMENTLESS HIP STEM	LZO	MEDACTA INTERNATIONAL SA		166565	07630030802652

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention