MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; PROSTHESIS, SHOULDER

Catalog Number 113042

Device Problem Material Erosion (1214)

Patient Problem Metal Related Pathology (4530)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: comp conv glen liner e1 cat# 110005237 lot# 375420.Comp cnv glen base non ha cat# 110005273 lot# 385170.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02457 , 0001825034 - 2021 - 02459.

Event Description

It was reported that a patient underwent a revision procedure approximately 30 months post implantation due to disassociation of the glenoid poly and baseplate.Metallosis occurred between the baseplate and humeral head due to the disassociation.Poly and humeral head were removed and patient was converted to reverse.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, this device was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, this device was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: VERSA-DIAL 46X18X53 HUM HEAD
• Type of Device: PROSTHESIS, SHOULDER
• 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: 12408316
• MDR Text Key: 269372691
• Report Number: 0001825034-2021-02458
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)280831(10)020990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040610
• 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,Followup
• Report Date: 01/05/2022

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: Health Professional
• Device Catalogue Number: 113042
• Device Lot Number: 020990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2018
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male