MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL TAPER ADAPTOR 25MM; SHOULDER PROSTHESIS

Catalog Number 110031378

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00836, 0001825034 - 2022 - 00835.

Event Description

It was reported that the glenosphere disassociated from vrs baseplate.Despite successful patient follow up appointments at 3 and 6 months postoperatively showing good implant alignment, the patient was seen in the office with a disassociated glenosphere.The 36mm glenosphere and its taper adaptor had dislocated from the vrs baseplate.Upon revision surgery, new implants of the same dimensions were successfully placed.The central screw from the initial surgery was removed and not replaced at the revision.It was noted that the screw head may have been proud of fully seated within the vrs boss when checked with the vrs inserter prior to screw removal.The vrs inserter sat flush against the face of the vrs implant after the central screw was removed.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d9, g3, g6, h1, h2, h3, h6, h10 complaint sample was evaluated and the reported event was confirmed.Reported event was also confirmed by review of radiographs and medical records.Visual inspection of the returned products identified found light scratches and discoloration on the polished surface.Also found an unknown fractured piece within the threaded area that could not be identified.Review of the available medical records identified the following: (b)(6) 2022 appointment: - increasing pain, poor forward elevation, - x-ray ap & lateral right shoulder head disassociated from baseplate - revision surgery planned.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 additional event information is available at the time of this report.

• Brand Name: VERSA-DIAL TAPER ADAPTOR 25MM
• Type of Device: SHOULDER PROSTHESIS
• 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: 14053083
• MDR Text Key: 288876721
• Report Number: 0001825034-2022-00632
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304834026
• UDI-Public: (01)00880304834026(17)310406(10)565980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152754
• 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: 06/07/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110031378
• Device Lot Number: 565980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female