MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN SHELL; PROSTHESIS HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was able to be confirmed through review of up notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk, stem, lot # unk.Item # unk, head, lot # unk.Item # unk, liner, lot # unk.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-09840, 0001825034-2018-09841, 0001825034-2018-09843.

Event Description

It was reported that in less than a month post implantation, the patient had developed a dvt and pe that was treated with aggressive anticoagulation.Attempts have been made and no further information has been provided.

• Brand Name: BIOMET UNKNOWN SHELL
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7989988
• MDR Text Key: 124505448
• Report Number: 0001825034-2018-09842
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 10/22/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 111