FDA Adverse Event Injury Summary report: N

AEQUALIS FLEX REVIVE

MDR report key: 11386670 · Received February 26, 2021

Report

Report Number: 3004983210-2021-00017
Event Type: Injury
Date Received: February 26, 2021
Date of Event: January 2, 2021
Report Date: April 22, 2021
Manufacturer: TORNIER INC
Product Code: KWS
PMA / PMN Number: K191318
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

H6: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. PHOTOS WERE SENT FROM THE INVESTIGATION TEAM IN FRANCE CONFIRMING THE DEVICE TO BE IN THE CONDITION DESCRIBED IN THE EVENT DESCRIPTION. THE PHOTOS REVEALED BOTH DOVETAILS ON THE DISTAL PORTION OF THE DEVICE HAVE BEEN BROKEN OFF AND THE CAPTURE SCREW OF THE PROXIMAL BODY TRIAL IS FULLY EXTENDED.

Description of Event or Problem · 0

ALLEGEDLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE SHOULDER. ALLEGEDLY, THE TRIAL COMPONENT JAMMED IN THE SCLEROTIC CHANNEL. AFTER 20 ATTEMPTS AT REMOVAL, THE TRIAL COMPONENT BROKE AND ONLY THE BODY CAME OUT. THE REMAINING SHAFT WAS REMOVED WITH AN ACCOMPANYING FRACTURE OF THE CORTEX.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

ALLEGEDLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE SHOULDER. ALLEGEDLY, THE TRIAL COMPONENT JAMED IN THE SCLEROTIC CHANNEL. AFTER 20 ATTEMPTS AT REMOVAL, THE TRIAL COMPONENT BROKE AND ONLY THE BODY CAME OUT. THE REMAINING SHAFT WAS REMOVED WITH AN ACCOMPANYING FRACTURE OF THE CORTEX.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
282061	AEQUALIS FLEX REVIVE	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	KWS	TORNIER INC	ARS742502	CR1118319

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention