UNKNOWN SHOULDER HUMERAL BODY

Report

Report Number: 1818910-2018-56321
Event Type: Injury
Date Received: March 28, 2018
Report Date: April 2, 2018
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: KWS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

(B)(4)NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

AWARENESS/ALERT DATE WAS PREVIOUSLY REPORTED AS (B)(6) 2018 IN ERROR. THE AWARENESS DATE SHOULD HAVE BEEN (B)(6) 2018 AS THAT WAS WHEN THE LITERATURE REVIEW WAS DONE. THE CORRECT DATE SHOULD BE (B)(6) 2018.

Description of Event or Problem · 1

ARTICLE REVIEWED ENTITLED: "THE REVERSE SHOULDER: PROMISES AND PITFALLS", BY CARL J. BASAMANIA, MD, PUBLISHED IN SEMINARS IN ARTHROPLASTY (SEMIN ARTHRO 15:176-182 2005). AUTHOR PROVIDES SURGICAL TECHNIQUE AND POTENTIAL ISSUES EXPERIENCED IN THE USE OF THE DEPUY DELTA III REVERSE SHOULDER PROSTHESES. THERE WERE TWO REPORTED COMPLICATIONS: AN EPISODE OF SCAPULAR NOTCHING THAT LED TO A FRANK FRACTURE OF THE GLENOID-SCAPULAR NECK; AND AN EPISODE OF SHOULDER DISLOCATION REQUIRING REVISION TO ADD AN ADDITIONAL HUMERAL SPACER TO "TIGHTEN" THE JOINT. THESE ADVERSE EVENTS WILL BE ADDRESSED SEPARATELY IN TWO COMPLAINTS. THIS COMPLAINT WILL ADDRESS THE REPORTED GLENOID/SCAPULAR NECK FRACTURE CAUSED BY SCAPULAR NOTCHING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
220806	UNKNOWN SHOULDER HUMERAL BODY	SHOULDER HUMERAL BODY	KWS	DEPUY ORTHOPAEDICS, INC. 1818910

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention