FDA Adverse Event Injury Summary report: N

STEM: SMS SOLID SMS SOLID STEM LAT SIZE 11

MDR report key: 10572823 · Received September 23, 2020

Report

Report Number: 3005180920-2020-00624
Event Type: Injury
Date Received: September 23, 2020
Date of Event: August 24, 2020
Report Date: September 23, 2020
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030888830
PMA / PMN Number: K181693
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 23-SEP-2020: LOT 1905380: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2019. EXPIRATION DATE: 18-AUG-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDCAL AFFAIRS DIRECTOR FEMORAL STEM LOOSENING OCCURRED IN A YOUNG MAN ((B)(6) YEAR-OLD). THE STEM HAD BEEN PLACED AFTER A TRAUMATIC FRACTURE, TREATED WITH CERCLAGE. IT'S VERY LIKELY THAT THE FRACTURE DID NOT HEAL COMPLETELY OR THAT THE HEALING PROCESS COMPROMISED STEM STABILITY. THE HEALING PROCESS CAN RESULT IN BONE DIMENSIONAL CHANGES THAT MAY MAKE THE STEM BECOME UNDERSIZED FOR THE "NEW" FEMUR. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

Description of Event or Problem · 1

4 MONTHS AFTER THE PRIMARY SURGERY, DUE TO PERIPROSTHETIC FRACTURE WHICH WAS CAUSED FROM FALLING, THE PATIENT WAS REVISED. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD, STEM, AND LINER. NOW, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL STEM 7 MONTHS AFTER THE FIRST REVISION SURGERY. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1038620	STEM: SMS SOLID SMS SOLID STEM LAT SIZE 11	CEMENTLESS HIP STEM	LZO	MEDACTA INTERNATIONAL SA	01.36.071	1905380	07630030888830

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention