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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN E1 MAXROM LINER; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. BIOMET UNKNOWN E1 MAXROM LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Hematoma (1884)
Event Date 02/14/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk , stem, lot # unk; item # 157454, head, lot # unk; item # unk, shell, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05655, 0001825034-2018-05656, 0001825034-2018-05657.
 
Event Description
It was reported that approximately 3 weeks post implantation, the patient underwent an i&d of a hematoma with positive cultures.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001825034-2015-01207.
 
Event Description
Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001825034-2015-01207.
 
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Brand Name
BIOMET UNKNOWN E1 MAXROM LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7761756
MDR Text Key116389026
Report Number0001825034-2018-05658
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 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
Patient Weight129
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