MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP CONV GLEN LINER VIVACIT-E; SHOULDER, PROSTHESIS

Catalog Number 110035767

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported that the patient was revised due to bearing disassociation approximately six months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 -02267 d10: mini tray std cocr +0 offset cat: 110031399 lot: 65949545.Versa-dial/comp ti std taper cat: 118001 lot: 808600.Comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7505348.Hmrl bearing 36 mm std vite cat: 110031424 lot: 65761078.Versa-dial 46x18x53 hum head cat: 113042 lot: j7298805.Versa-dial/comp ti std taper cat: 118001 lot: j7379786.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified wear and damage noticed on radius and side by hash marks and underneath posts near taper.Product identifier measurement was taken and was within tolerance.Part and lot numbers confirmed.Medical records for the initial surgery were provided and reviewed by a health care professional.Review of the available records identified the following: rotator cuff intact.Glenoid convertible baseplate.Anatomic total shoulder performed without complications.Intraop imaging show good alignment of components.Device history record was reviewed and no discrepancies were found.The reported event is not confirmed; the revision is confirmed as pictures were provided and product returned, however the occurrence of disassociation cannot be confirmed.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 further event information available at the time of this report.

• Brand Name: COMP CONV GLEN LINER VIVACIT-E
• Type of Device: SHOULDER, PROSTHESIS
• 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: 17611212
• MDR Text Key: 321825352
• Report Number: 0001825034-2023-02012
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: 110035767
• Device Lot Number: 65163943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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: 56 KG