FDA Adverse Event Injury Summary report: N

MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5

MDR report key: 7402529 · Received April 6, 2018

Report

Report Number: 3005180920-2018-00214
Event Type: Injury
Date Received: April 6, 2018
Date of Event: March 5, 2018
Report Date: April 6, 2018
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030885655
PMA / PMN Number: K151531
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 03 APRIL 2018; LOT 163569: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 SEPTEMBER 2016 EXPIRATION DATE: 2021-08-22; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 06 APRIL 2018; PERIPROSTHETIC FRACTURE IN AN ELDERLY LADY FEW DAYS AFTER PRIMARY CEMENTLESS THA. THERE IS NO REPORT OF A TRAUMATIC EVENT, BUT THIS MAY WELL HAVE HAPPENED DURING THE INITIAL REEDUCATION DAYS. IT MAY ALSO BE THE CONSEQUENCE OF A HIDDEN INTRAOPERATIVE FRACTURE, WHICH IS A COMMON ADVERSE EVENT THAT MAY HAPPEN DURING FEMORAL PREPARATION. WITH THE INFORMATION AVAILABLE, NO FINAL CONCLUSION CAN BE DRAWN, BUT THERE IS NO INDICATION THAT THE PROBLEM MAY BE DUE TO A FAULTY DEVICE

Description of Event or Problem · 1

A PATIENT HAD A PERI-PROSTHETIC FRACTURE FOUND THROUGH X-RAY TAKEN SURGEON TWO DAYS AFTER PRIMARY. SURGEON REVISED THE IMPLANT WITH QUADRA- R SIZE#1 SUCCESSFULLY. CERCLAGE APPLIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
245921	MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5	CEMNTLESS HIP STEM	LZO	MEDACTA INTERNATIONAL SA		163569	07630030885655

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention