MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VRS GLENOID; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number UNKNOWN VRS GLENOID

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

Patient Problems Erosion (1750); Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the patient underwent a primary implantation on an unknown date.Subsequently, the patient underwent a revision on an unknown date due to aseptic loosening with significant bone loss.Patient is currently waiting for a pmi shoulder device to be made.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: item# unknown stem; lot# unknown.G2: foreign - event occurred in switzerland.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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.

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.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 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: UNKNOWN VRS GLENOID
• 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: 17649429
• MDR Text Key: 322254928
• Report Number: 0001825034-2023-02022
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K202232
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN VRS GLENOID
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2023
• 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: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose