MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X21X43 HUM HEAD; PROSTHESIS, SHOULDER

Catalog Number 113034

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 07/13/2022

Event Type  Injury  

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/comp ti std taper cat# 118001 lot# 027330.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 - 02700.

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

This follow-up report is being submitted to relay additional information.H6: component code: proposed code: mechanical (g04)- head.Visual examination of the provided photo identified explanted products.However, as the parts were not returned, further analysis could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 1 month prior to revision: patient indicated when hanging clothes up when felt a pop.Range of motion issues and significant pain and weakness were also noted.Week prior to revision: ct found glenoid dislodged and loose in the anterior joint space surrounded by contrast.Revision: it was noted the stem had significant metallosis type of debris around it and resorption around the neck of the humerus.Stem was removed but appeared to be well fixed.It was also noted that the polyethylene over mold fractured at the interface with the post.Significant wear of the glenoid component was noted.The glenoid was significantly damaged with posterior erosion.A definitive root cause cannot be determined.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

No further event information is available at the time of this report.

• Brand Name: VERSA-DIAL 42X21X43 HUM HEAD
• 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: 15887829
• MDR Text Key: 304547867
• Report Number: 0001825034-2022-02701
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304212213
• UDI-Public: (01)00880304212213(17)291017(10)807310
• 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: 04/12/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 113034
• Device Lot Number: 807310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG