MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL TRAY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient has been indicated for a revision due to unknown reasons.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

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Part and lot identification are necessary for review of device history records, neither were provided.No product was returned; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the humeral tray appears to be perched upon the inferior margin of the glenosphere.Bone quality appears normal.A definitive root cause could not 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.

• Brand Name: UNKNOWN HUMERAL TRAY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9770048
• MDR Text Key: 191735211
• Report Number: 0001822565-2020-00759
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention