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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Bacterial Infection (1735); Hematoma (1884)

Event Date 08/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device history record 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: 0001825034-2018-05132, 0001825034-2018-05133, 0001825034-2018-05135.

Event Description

It was reported that approximately 4 weeks post implantation, the patient presented with pulmonary embolus and after aggressive anticoagulation, the patient developed a large thigh hematoma.The patient developed drainage to the wound with obvious breakdown of the hematoma products.Subsequently, the patient underwent hip irrigation and debridement with hematoma evacuation, wound revision, and placement of wound vac.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and correction information.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 4 weeks post implantation, the patient presented with pulmonary embolus and after aggressive anticoagulation, the patient developed a large thigh hematoma.The patient developed drainage to the wound with obvious breakdown of the hematoma products.Subsequently, the patient underwent hip irrigation and debridement with hematoma evacuation, wound revision, and placement of wound vac.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and correction information.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 4 weeks post implantation, the patient presented with pulmonary embolus and after aggressive anticoagulation, the patient developed a large thigh hematoma.The patient developed drainage to the wound with obvious breakdown of the hematoma products.Subsequently, the patient underwent hip irrigation and debridement with hematoma evacuation, wound revision, and placement of wound vac.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
• MDR Report Key: 7758987
• MDR Text Key: 116358491
• Report Number: 0001825034-2018-05134
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 111