MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Catalog Number	118001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 2.5 years post implantation due to disassociation of the glenoid and metal post.During the revision, found the stem with significant metallosis type of debris around it, resorption noted around the neck of the humerus and the calcar, synovitis resulting in a complete synovectomy, a piece of the polyethylene baseplate that fractured off and was left attached to the ingrowth post, wear to the glenoid, and significant glenoid damage with posterior erosion and a b2 type of configuration.All components were removed without complication and competitor product was implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: sm hybrid glenoid base 4mm cat# 113952 lot#676850; pt hybrid glen post regenerex cat# pt-113950 lot#757630; comp primary stem 10mm micro cat# 113610 lot# 178990; versa-dial 42x21x43 hum head cat# 113034 lot# 807310.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 - 01733; 0001825034 - 2022 - 01734; 0001825034 - 2022 - 02699; 0001825034 - 2022 - 02701.
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.
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.

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15887885
• Report Number: 0001825034-2022-02700
• Device Sequence Number: 5103452
• Product Code: MBF
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)291210(10)027330
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2022
• 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): 03/28/2023

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: 118001
• Device Lot Number: 027330
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG