FDA Adverse Event Injury Summary report: N

UNI GLENOID-PERIPHERAL LOCK SCRW

MDR report key: 11046528 · Received December 21, 2020

Report

Report Number: 1220246-2020-02418
Event Type: Injury
Date Received: December 21, 2020
Date of Event: November 27, 2020
Report Date: December 21, 2020
Manufacturer: ARTHREX, INC.
Product Code: PHX
UDI-DI: 00888867057722
PMA / PMN Number: K142863
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD A REVERSE SHOULDER REPLACEMENT PERFORMED ON (B)(6) 2015. THE PERIPHERAL SCREWS ON THE BASEPLATE HAD BROKEN REQUIRING THE PATIENT TO HAVE A REVISION SURGERY (B)(6) 2020 AT A DIFFERENT FACILITY. THE GLENOID COMPONENTS WERE REVISED AND THE IMPLANT WAS REPLACED WITH AN MGS GLENOID BASEPLATE. EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY AT TIME OF PROCEDURE. THE FOLLOWING ORIGINAL IMPLANTS WERE EXPLANTED: AR-9120-01, GLENOID BASEPLATE, LOT 140122110. AR-9145-30, UNI GLENOID PERIPHERAL LOCKING SCREW, LOT 150018908. AR-9145-24, UNI GLENOID PERIPHERAL LOCKING SCREW, LOT 140123008. ADDITIONAL INFORMATION OBTAINED 12/1/2020: THE PATIENT DID NOT SUFFER ANY TRAUMA OR FALL PRIOR TO THE REVISION. THE SURGEON NOTED THE PATIENT WAS AN ACTIVE GOLFER AND TENNIS PLAYER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1514736	UNI GLENOID-PERIPHERAL LOCK SCRW	SHOULDER PROSTHESIS, REVERSE CONFIGURATION	PHX	ARTHREX, INC.	UNI GLENOID-PERIPHERAL LOCK SCRW	150018908	00888867057722

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other