MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL ( TM) SHOULDER SYSTEM MODULAR HEAD W/ VARIABLE OFFSET; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER

Catalog Number 113044

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

Patient Problems Erosion (1750); Scar Tissue (2060); Subluxation (4525); Muscle/Tendon Damage (4532)

Event Date 05/02/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).E1: full establishment name - (b)(6) hospital.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient previously underwent a shoulder revision approximately three (3) months after initial implantation and was converted to a hemi-arthroplasty.Subsequently, the patient underwent a second revision approximately nine (9) months later due to severe anterosuperior subluxation of the humerus and severely eroded glenoid.The patient was then converted to a reverse shoulder arthroplasty.Attempts have been made and no further information has been provided.

• Brand Name: VERSA-DIAL ( TM) SHOULDER SYSTEM MODULAR HEAD W/ VARIABLE OFFSET
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER
• 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: 18994923
• MDR Text Key: 338829653
• Report Number: 0001825034-2024-00876
• Device Sequence Number: 1
• Product Code: MBF
• 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: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 113044
• Device Lot Number: 817890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female