MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR MD; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 110032420

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Osteopenia/ Osteoporosis (2651); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device product code - phx.Concomitant medical products: item# ti-115310; lot# 698430 report source foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 underwent a revision approximately two (2) days post-implantation due to disassociation.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified damage on the backside of the plate and taper feature of the baseplate.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the left shoulder demonstrates a reverse total shoulder arthroplasty with dislocation of the glenosphere from the baseplate.Osteopenia is present.No definite evidence for injury or trauma.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP AUG MINI BSPLT W TPR MD
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 14777675
• MDR Text Key: 295030258
• Report Number: 0001825034-2022-01484
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)251019(10)64896068
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K172502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110032420
• Device Lot Number: 64896068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• 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