FDA Adverse Event Injury Summary report: N

EQUINOXE

MDR report key: 8451252 · Received March 26, 2019

Report

Report Number: 1038671-2019-00189
Event Type: Injury
Date Received: March 26, 2019
Date of Event: February 15, 2019
Report Date: April 29, 2020
Manufacturer: EXACTECH, INC.
Product Code: KWT
PMA / PMN Number: K061454
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

SECTION H10: (A1) PATIENT IDENTIFIER (IN CONFIDENCE): (B)(6). (A2) AGE AT THE TIME OF EVENT: 64 YEARS. (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D4) EXPIRATION DATE: 30-JAN-2028, UNIQUE IDENTIFIER (UDI) (B)(4). (D6) IF IMPLANTED, GIVE DATE: 14-DEC-2018. (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K061454. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF INCOMPLETE SEATING OF THE TORQUE DEFINING SCREW, THE HUMERAL LINER, OR A COMBINATION OF THE TWO AT THE TIME OF IMPLANTATION WHICH MAY HAVE CONTRIBUTED TO DISASSOCIATION OF THE HUMERAL LINER FROM THE HUMERAL ADAPTER TRAY. (H4) DEVICE MANUFACTURE DATE: 31-JAN-2018. (H6) EVALUATION CODES: 1924, 2923. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (E2) HEALTH PROFESSIONAL?: YES. (G3) REPORT SOURCE: SHOULD OF BEEN HEALTH PROFESSIONAL ON FIRST REPORT.

Additional Manufacturer Narrative · 1

PENDING EVALUATION.

Description of Event or Problem · 1

INDEX SURGERY: (B)(6) 2018. REVISION DUE TO DISSOCIATION. PATIENT WAS ON VACATION AND MOVED HIS ARM BACK AND FELT A POP 6 WEEKS POST OP. UPON X-RAY, POLY HAD DISASSOCIATED FROM HUMERAL TRAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
245350	EQUINOXE	EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM	KWT	EXACTECH, INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| R