FDA Adverse Event Injury Summary report: N

HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP

MDR report key: 8483671 · Received April 4, 2019

Report

Report Number: 1220246-2019-01008
Event Type: Injury
Date Received: April 4, 2019
Date of Event: August 8, 2018
Report Date: April 4, 2019
Manufacturer: ARTHREX, INC.
Product Code: PHX
UDI-DI: 00888867061293
PMA / PMN Number: K142863
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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. DISPOSITION OF EXPLANTED DEVICE IS UNKNOWN. 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 UNDERGONE A TOTAL REVERSE SHOULDER PROCEDURE ON (B)(6) 2018 DURING WHICH THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-9502F-36RCPC (LOT 170027905); AR-9502F-36CPC (LOT 170018606); AR-9501-06P (LOT 170088903); AR-9503S-03 (170085610); AR-9504S-INF (LOT 160071710); AR-9120-01 (LOT 170115115); AR-9165-20 (LOT 170056412); AR-9145-24 (LOT 170101712). PATIENT ALSO UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DURING WHICH THE AR-9503S-03 WAS EXPLANTED AND AN AR-9503S-06 (LOT 170150113)WAS IMPLANTED. THIS REPORT (CASE (B)(4)) IS TO DOCUMENT THE REVISION SURGERY. PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION WHICH IS BEING REPORTED UNDER THE FOLLOWING COMPLAINT NUMBERS: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
278630	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP	SHOULDER PROSTHESIS, REVERSE CONFIGURATION	PHX	ARTHREX, INC.	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP	170085610	00888867061293

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other