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

Catalog Number UNK GLENOID REMOVAL FORK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)

Event Date 03/11/2024

Event Type  Injury  

Event Description

It was reported by the pmi group that a patient underwent a left shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day for an unknown reason.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.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.

Manufacturer Narrative

D6a: this field will be corrected to a blank date as the reported device is being updated from an implant to an instrument with the additional event details received.Therefore, an implant date is no longer applicable.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will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.

Event Description

It was reported by the pmi group that a patient underwent a left shoulder arthroplasty after experiencing a proximal humeral fracture.Subsequently, the patient is being considered for a pmi product on an unknown day due to the glenoid fracturing during the initial implantation while the surgeon was using the glenoid removal fork.As a result, the patient received a hemi to wait for a pmi to be made.It was noted that contributing factors to the event includes previous trauma and poor bone quality.

• Brand Name: UNK GLENOID REMOVAL FORK
• 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: 19030685
• MDR Text Key: 339208746
• Report Number: 0001825034-2024-00915
• 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,Followup
• Report Date: 04/29/2024
• 2 Devices were Involved in the Event: 1 2

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: UNK GLENOID REMOVAL FORK
• 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: 03/13/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female