MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK BASEPLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number UNK BASEPLATE

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).E1: full establishment name - (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.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

It was reported by the pmi group that a patient underwent a left shoulder arthroplasty on an unknown date.Subsequently, the patient underwent a revision approximately eleven (11) months ago to receive pmi product due to loosening of the glenoid component.The patient was also noted to have poor bone stock around the central post.Attempts have been made and no further information has been provided.

• Brand Name: UNK BASEPLATE
• 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: 19116401
• MDR Text Key: 340282725
• Report Number: 0001825034-2024-00332
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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
• Report Date: 04/16/2024

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: UNK BASEPLATE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 70 YR
• Patient Sex: Female