FDA Adverse Event Injury Summary report: N

STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5

MDR report key: 10975810 · Received December 9, 2020

Report

Report Number: 3005180920-2020-00874
Event Type: Injury
Date Received: December 9, 2020
Date of Event: November 8, 2020
Report Date: December 9, 2020
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030803239
PMA / PMN Number: K170845
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IS
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 18 NOVEMBER 2020: LOT 1903498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2019. EXPIRATION DATE: 2024-07-24. 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 MANAGER: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO STEM SUBSIDENCE AND FRACTURE IN THE CALCAR REGION. ACCORDING TO THE REPORT, THE PATIENT WAS (B)(6) YEAR OLD AND AFFECTED BY OSTEOPOROSIS. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

Description of Event or Problem · 1

4 WEEKS AFTER PRIMARY THR. PATIENT CAME TO THE CLINIC COMPLAINING ON PAIN. X-RAYS SHOW SUBSIDENCE OF THE FEMORAL STEM AND FRACTURE OF THE CALCAR. REVISION OF THE STEM PERFORMED WITH DIFFERENT MANUFACTURER STEM. IT SHOULD BE NOTED THAT THE PATIENT HAS SEVERE OSTEOPOROSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1443503	STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5	CEMENTLESS ANATOMICAL HIP STEM	LZO	MEDACTA INTERNATIONAL SA	01.13.105L	1903498	07630030803239

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Required Intervention