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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. BIOMET UNKNOWN SHELL HIP PROSTHESIS Back to Search Results
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.
 
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Brand NameBIOMET UNKNOWN SHELL
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7758987
MDR Text Key116358491
Report Number0001825034-2018-05134
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PNI
Number of Events Reported1
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 Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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