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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/21/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # unk, head, lot # unk.Item # unk, shell, lot # unk.Item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04847, 0001825034-2018-04852, 0001825034-2018-04853.Reported event was confirmed due to operative note information received from the customer.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.

Event Description

It was reported that approximately 14 days post implantation, a patient had presented with increasing pain and decreased mobility in the hip.Patient had noted increased swelling on the anterior aspect of the thigh and had some drainage of serous material.Patient underwent incision and drainage of hip hematoma/seroma.Attempts have been made, and no further information has been provided.

• Brand Name: UNKNOWN STEM
• Type of Device: HIP PROSTHESIS
• 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: 7752993
• MDR Text Key: 116120839
• Report Number: 0001825034-2018-04851
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• 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
• Date Manufacturer Received: 07/12/2018
• 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 Age: 67 YR
• Patient Weight: 48