MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant product(s): 118000-00, 25mm versa-dial taper adaptor, 992640.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 07066.

Event Description

It was reported that the patient underwent initial shoulder arthroplasty.During the event, it was reported that the glenosphere did not engage with the baseplate.The baseplate popped off after the surgery; therefore, the surgeon had to immediately perform a revision surgery to replace the dislocated glenosphere and adaptor.No delay was reported.No additional patient consequences were reported.

Manufacturer Narrative

Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6859414
• MDR Text Key: 85900832
• Report Number: 0001825034-2017-07065
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 137570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention