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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Hematoma (1884)

Event Date 07/12/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reviews of operative notes confirm that the patient underwent incision and drainage with irrigation of the left hip due to non-healing wound.Drainage developed 24 hours post-operative at the distal aspect of the wound.Identified large hematoma and taken back to surgery to perform irrigation and debridement.Upon opening the incision, noted the large hematoma and evacuated it.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.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.Concomitant medical products: item # unk, stem, lot # unk; item # unk, shell, lot # unk; item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-04912, 0001825034-2018-04913, 0001825034-2018-04914.

Event Description

It was reported that approximately 2 weeks post implantation, patient had developed drainage through the distal aspect of the wound, and had a large subcutaneous hematoma.Subsequently, patient underwent incision and drainage with irrigation.Attempts have been made, and no further information has been provided.

• Brand Name: BIOMET UNKNOWN HEAD
• 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: 7753930
• MDR Text Key: 116210976
• Report Number: 0001825034-2018-04911
• Device Sequence Number: 1
• Product Code: JDG
• 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: 07/25/2018

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: 31 YR
• Patient Weight: 207