FDA Adverse Event Injury Summary report: N

STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

MDR report key: 12390512 · Received August 31, 2021

Report

Report Number: 3005180920-2021-00696
Event Type: Injury
Date Received: August 31, 2021
Date of Event: August 4, 2021
Report Date: August 31, 2021
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630971240834
PMA / PMN Number: K191816
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 11.AUGUST.2021 LOT 1901214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-FEB-2020. EXPIRATION DATE: 2025-01-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2010631. BATCH REVIEW PERFORMED ON 11.08.2021: LOT 2010631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-FEB-2021. EXPIRATION DATE: 2026-01-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

2 MONTHS AFTER THE PREVIOUS SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE PROXIMAL BODY AND HEAD, PERFORMED A WASHOUT, AND REPLACED THE PROXIMAL BODY AND HEAD WITH NEW COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT HAD PROXIMAL BODY AND HEAD REVISION DUE TO STEM SUBSIDENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1295978	STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD	CEMENTLESS PROXIMAL BODY	LZO	MEDACTA INTERNATIONAL SA	01.22.005	1901214	07630971240834

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention