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

Catalog Number 118001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 07/13/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 304548136
• Report Number: 0001825034-2022-02700
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)291210(10)027330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060716
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG