MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; PROSTHESIS, SHOULDER

Catalog Number	113032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Versa-dial/comp ti std taper cat# 118001 lot# 041400, comp primary stem 12mm micro cat# 113612 lot# 64578937, 4 peg mod glen sz 2 cat# sagl2042 lot# 64768904, modular post tm cat# sagp0002 lot# 64831492.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 1150, 0001825034 - 2022 - 01151.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 7 months postimplantation due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon 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: VERSA-DIAL 42X18X46 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: 14288708
• Report Number: 0001825034-2022-01152
• Device Sequence Number: 20185349
• Product Code: MBF
• UDI-Device Identifier: 00880304212206
• UDI-Public: (01)00880304212206(17)301026(10)063920
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/24/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 113032
• Device Lot Number: 063920
• Was Device Available for Evaluation?: No
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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 Age: 50 YR
• Patient Sex: Female