FDA Adverse Event Injury Summary report: N

EQUINOXE

MDR report key: 8756309 · Received July 2, 2019

Report

Report Number: 1038671-2019-00351
Event Type: Injury
Date Received: July 2, 2019
Date of Event: June 6, 2019
Report Date: April 1, 2020
Manufacturer: EXACTECH, INC.
Product Code: KWT
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

SECTION H10: (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D4) CATALOG NUMBER: 304-21-07, SERIAL NUMBER: (B)(6), UNIQUE IDENTIFIER (UDI) #: (B)(4). (E3) OCCUPATION: PHYSICIAN. (E4) INITIAL REPORTER ALSO SENT REPORT TO FDA?: NO. (G5) PMA/510(K)NUMBER: K092900 K101909. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE HUMERAL STEM. THE REPORTED WEAR WAS LIKELY THE RESULT OF SCAPULAR NOTCHING. (H4) DEVICE MANUFACTURE DATE: 02-MAR-2012. (H6) EVALUATION CODES: 1924, 4002. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (SECTION F) PLEASE DISREGARD F6 AND F8 IN PREVIOUS REPORT. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 05-JUN-2019.

Additional Manufacturer Narrative · 1

PENDING EVALUATION. CONCOMITANT MEDICAL DEVICES: +0 HUMERAL TRAY. +0 42 LINER. 42 GLENOSPHERE. GLENOSPHERE LOCKING SCREW.

Description of Event or Problem · 1

PRIMARY SURGERY: 2013. REVISION DUE TO OSTEOLYSIS, POLY WEAR, AND A LOOSE HUMERUS. UPON REMOVAL THE STEM WAS LOOSE, AND THE POLY SHOWED SOME WEAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
549634	EQUINOXE	FRACTURE STEM	KWT	EXACTECH, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Hospitalization\| R	SEE H10.