ECLIPSE CAGE SCREW M, 35MM

MDR report key: 10842534 · Received November 16, 2020

Report

Report Number: 1220246-2020-02334
Event Type: Injury
Date Received: November 16, 2020
Date of Event: July 2, 2020
Report Date: November 18, 2020
Manufacturer: ARTHREX, INC.
Product Code: QHQ
PMA / PMN Number: K183194
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

COMPLAINT NOT CONFIRMED, NO ABNORMALITY WAS OBSERVED THAT MAY HAVE CONTRIBUTED TO THE EVENT.

Additional Manufacturer Narrative · 1

COMPLAINT NOT CONFIRMED, NO ABNORMALITY WAS OBSERVED THAT MAY HAVE CONTRIBUTED TO THE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT LOOSENING AND BREAKAGE OF THE GLENOID COMPONENT DUE TO PE ABRASION OCCURRED. REVISION SURGERY PERFORMED WITH PROSTHESIS REMOVAL, IMPLANTATION OF AN INVERSE SHOULDER PROSTHESIS ON THE RIGHT FROM A DIFFERENT MANUFACTURER. INTRAOPERATIVELY, DEFECT OF THE GLENOID WAS CONFIRMED. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2013, DATE OF REVISION SURGERY WAS (B)(6) 2020. MALE PATIENT, YOB: (B)(6). NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. ADDITIONAL INFORMATION OBTAINED 13-JUL-2020: THE PATIENT SUFFERED FROM PAIN AND WENT TO THE HOSPITAL, NO KNOWN TRAUMA THAT COULD HAVE CAUSED THE PAIN. PATIENT DOES NOT HAVE AN EXTRAORDINARILY HIGH BMI OR ANY KNOWN EXTRAORDINARILY STRESS. ADDITIONAL INFORMATION OBTAINED 27-OCT-2020: THE PART NUMBERS OF THE EXPLANTED ARTHREX DEVICES HAS BEEN PROVIDED AND ARE AS FOLLOWS: AR-9105-01 W/ BATCH 1221011; AR-9343-16 W/ BATCH 1295122004; AR-9300-43CPC W/ BATCH 12.055; AR-9301-02 W/ BATCH 12.363.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1311525	ECLIPSE CAGE SCREW M, 35MM	TOTAL SHOULDER ARTHROPLASTY SYSTEM	QHQ	ARTHREX, INC.	ECLIPSE CAGE SCREW M, 35MM	12.363

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other