MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; SHOULDER PROSTHESIS

Catalog Number 115396

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  

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

(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 - 00632, 0001825034 - 2022 - 00836.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 reported event was also confirmed by review of radiographs and medical records.Review of the available medical records identified the following: 21 feb 2022 appointment: - increasing pain, poor forward elevation, - x-ray ap & lateral right shoulder head disassociated from baseplate - revision surgery planned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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: COMP RVS CNTRL 6.5X30MM ST/RST
• 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: 14053076
• MDR Text Key: 288878193
• Report Number: 0001825034-2022-00835
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080642
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115396
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Sex: Female