FDA Adverse Event Injury Summary report: N

EQUINOXE

MDR report key: 8311563 · Received February 6, 2019

Report

Report Number: 1038671-2019-00065
Event Type: Injury
Date Received: February 6, 2019
Date of Event: January 24, 2019
Report Date: November 19, 2019
Manufacturer: EXACTECH, INC.
Product Code: KWT
PMA / PMN Number: K113309
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

SECTION H10: (B2) ADDED CHECK FOR "HOSPITALIZATION - INITIAL OR PROLONGED" (D4) EXPIRATION DATE: 10-APR-2022, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D5) OPERATOR OF DEVICE: HEALTH_CARE_PROFESSIONAL (G1) MDR REPORTING CONTACT NAME: (B)(6). (G5) PMA/510(K)NUMBER: K113309. (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE GLENOID COMPONENT BOTTOMING OUT ON THE GLENOID WALL UPON IMPLANTATION, POSSIBLY RELATED TO THE SMALL GLENOID ANATOMY, WHICH LED TO SPLAYING OF THE POSTERIOR INFERIOR PEG AND ULTIMATE FAILURE. HOWEVER, THE SURGEON STATED THAT THE PATIENT EXPERIENCED FAILURE OF THE ROTATOR CUFF WHICH MAY HAVE LED TO INSTABILITY AND, AS A RESULT, SHEAR STRESS ON THE GLENOID. BECAUSE THE EXPLANTED DEVICE WAS NOT RETURNED TO EXACTECH FOR EVALUATION AND NO ADDITIONAL X-RAY IMAGES WERE PROVIDED, SPECIFICALLY AN AXILLARY VIEW, IT IS NOT POSSIBLE TO DETERMINE THE UNDERLYING CAUSE FOR THIS CASE. (H4) DEVICE MANUFACTURE DATE: (B)(6) 2017. *NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A1, A2, A3, A4, A5, B6, B7, E3, G8, H6, H7

Additional Manufacturer Narrative · 1

PENDING EVALUATION.

Description of Event or Problem · 1

INDEX SURGERY: (B)(6) 2019. REVISION DUE TO CAGE GLENOID DISASSOCIATING FROM THE PEGS WITHOUT ANY TRAUMATIC EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
104715	EQUINOXE	EQUINOXE CAGE GLENOID SMALL, ALPHA	KWT	EXACTECH, INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R