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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Inflammation (1932)

Event Date 12/14/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of operative notes confirms that the patient underwent irrigation and debridement of surgical wound with revision of the scar for wound breakdown, dehiscence, redness, warmth, infection.Inflammatory markers were elevated.A hip aspiration revealed 2,000 wbc and 12% neutrophils.Cultures taken during the i&d were positive for staphylococcus, coagulase negative.Operative notes state the tensor fascia was healed and intact so the surgeon elected not to go deep into the joint, no product was removed or exchanged.The patient was placed on oral antibiotics and infection diseases follow up.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.Medical devices: 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 - 05042, 0001825034 - 2018 - 05043, 0001825034 - 2018 - 05045.

Event Description

It was reported that approximately 1 month post implantation, patient had presented with some wound breakdown and dehiscence.Labs indicated inflammatory markers were elevated.The hip joint was aspirated, which revealed 2000 wbcs with 12% neutrophils.At the time of the initial surgery, cultures were negative for growth.Wound revision was recommended, and patient underwent irrigation and debridement of the l hip.Attempts have been made and no further information has been provided.

• Brand Name: BIOMET UNKNOWN SHELL
• 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: 7752794
• MDR Text Key: 116106075
• Report Number: 0001825034-2018-05044
• 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: 07/26/2018

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: 73 YR
• Patient Weight: 83