EQUINOXE

Report

Report Number: 1038671-2019-00053
Event Type: Injury
Date Received: February 6, 2019
Date of Event: August 31, 2018
Report Date: November 22, 2019
Manufacturer: EXACTECH, INC.
Product Code: KWT
PMA / PMN Number: K063569
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

D4: ADDED SERIAL NUMBER (B)(6).

Additional Manufacturer Narrative · 0

PATIENT IDENTIFIER (IN CONFIDENCE): (B)(6). ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. EXPIRATION DATE: 10-MAY-2023, UNIQUE IDENTIFIER (UDI) #: (B)(4). OPERATOR OF DEVICE: HEALTH_CARE_PROFESSIONAL. IF IMPLANTED, GIVE DATE: (B)(6) 2018 IF EXPLANTED, GIVE DATE: (B)(6) 2018 PMA/510(K)NUMBER: K063569. PATIENT WAS REVISED ON 12/15/2018. ONLY THE TRAY, LINER AND GLENOSPHERE WERE REPLACED. DEVICE MANUFACTURE DATE: 11-MAY-2018. LABELED FOR SINGLE USE?: YES. CORRECTIONS MADE IN THE FOLLOWING SECTION(S): INITIAL REPORTER: DR. (B)(6). HEALTH PROFESSIONAL?: YES. INITIAL REPORTER OCCUPATION: PHYSICIAN. INITIAL REPORTER ALSO SENT REPORT TO FDA?: NO. MDR REPORTING CONTACT: (B)(6). REPORT SOURCE: HEALTH PROFESSIONAL .

Additional Manufacturer Narrative · 0

THE ENGINEERING EVALUATION NOTED THAT THE REVISION REPORTED WAS LIKELY THE RESULT OF HETEROTROPIC OSSIFICATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative · 1

THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. PENDING EVALUATION.

Description of Event or Problem · 1

INDEX SURGERY: (B)(6) 2018. REVISION DUE TO HETEROTOPIC OSSIFICATION. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105843	EQUINOXE	EQ REV LOCKING SCREW	KWT	EXACTECH, INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Required Intervention