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

Catalog Number	113042
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001825034-2021-02458
• Device Sequence Number: 4182177
• Product Code: HSD
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)280831(10)020990
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male