FDA Adverse Event Injury Summary report: N

UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)

MDR report key: 8483510 · Received April 4, 2019

Report

Report Number: 1220246-2019-01000
Event Type: Injury
Date Received: April 4, 2019
Date of Event: March 21, 2018
Report Date: April 4, 2019
Manufacturer: ARTHREX, INC.
Product Code: HSD
UDI-DI: 00888867234215
PMA / PMN Number: K161782
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. THE DEVICE REMAINS IN PATIENT. 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. THE REVISION SURGERY IS BEING REPORTED UNDER CASE (B)(4). PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION. THE INFECTION IS BEING REPORTED UNDER THE FOLLOWING: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
275064	UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	HSD	ARTHREX, INC.	UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)	170027905	00888867234215

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other