ARCOM XL 44-36 RTNV+3 HMRL BRG

Report

Report Number: 0001825034-2012-02566
Event Type: Injury
Date Received: December 10, 2012
Date of Event: January 7, 2013
Report Date: November 16, 2012
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWS
PMA / PMN Number: PK080642
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY OR EXCESSIVE ACTIVITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02565 / 02566).

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02565-1 / 02566-1).

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT INITIAL REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO DISLOCATION. THE HUMERAL TRAY AND HUMERAL BEARING WERE REMOVED AND REPLACED.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT INITIAL REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT'S SHOULDER KEEPS DISLOCATING, REVISION PROCEDURE HAS NOT YET OCCURRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARCOM XL 44-36 RTNV+3 HMRL BRG	PROSTHESIS, SHOULDER	KWS	BIOMET ORTHOPEDICS	N/A	919800

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R