FDA Adverse Event Injury Summary report: N

EXPLOR 7X26MM IMPL STEM W/SCR

MDR report key: 5108583 · Received September 28, 2015

Report

Report Number: 0001825034-2015-04101
Event Type: Injury
Date Received: September 28, 2015
Date of Event: July 15, 2015
Report Date: September 28, 2015
Manufacturer: BIOMET SET
Product Code: KWI
PMA / PMN Number: PK051385
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, 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 6 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY.¿

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT AN ELBOW ARTHROPLASTY ON AN UNKNOWN SIDE ON (B)(6) 2014. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO THE SET SCREW BACKING OUT. THE HEAD WAS REMOVED AND REPLACED AND A NEW SET SCREW WAS IMPLANTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT ELBOW ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO THE SET SCREW BACKING OUT. THE HEAD WAS REMOVED AND REPLACED AND A NEW SET SCREW WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
638652	EXPLOR 7X26MM IMPL STEM W/SCR	PROSTHESIS, ELBOW	KWI	BIOMET SET	N/A	525930

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Hospitalization\| R