MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE® VIVACIT-E +3MM 40MM DIAMETER BEARING; POLYETHYLENE REVERSE SHOULDER PROSTHESIS CUP

Catalog Number 110031428

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: comprehensive reverse sholder glenosphere +3 36mm cat#(b)(4) lot# j7558972.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during an initial shoulder arthroplasty, the surgeon implanted a larger (40mm) bearing that is not meant to be used with a 36mm glenosphere.No harm was reported for the patient and there are no intentions to revise the patient at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMPREHENSIVE® VIVACIT-E +3MM 40MM DIAMETER BEARING
• Type of Device: POLYETHYLENE REVERSE SHOULDER PROSTHESIS CUP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18838047
• MDR Text Key: 336976028
• Report Number: 0001822565-2024-00774
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 0887868231599
• UDI-Public: (01)0887868231599(17)280127(10)65666795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110031428
• Device Lot Number: 65666795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male