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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZMR STEM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN ZMR STEM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00999.0001825034 - 2021 - 01000.
 
Event Description
It was reported that the initial left total hip arthroplasty was performed on an unknown date approximately 14 years ago with a metal-on-metal construct.Subsequently, the patient was revised on an unknown date approximately 6 or 7 years later due to pseudotumor.Initially, only the head was exchanged for a large poly head.There was still corrosion occurring at the taper of the neck and body junction, so the patient underwent a second revision.After the second revision, the patient was diagnosed with a staph infection and underwent two incision and drainage procedures with placement of antibiotic beads.The patient was placed on long-term antibiotics for bacterial suppression.Attempts have been made and no additional information is available.
 
Event Description
Upon reassessment of the reported event, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number : 1822565.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number : 1822565.
 
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Brand Name
UNKNOWN ZMR STEM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11648106
MDR Text Key244855059
Report Number0001825034-2021-00997
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/18/2021
Initial Date FDA Received04/12/2021
Supplement Dates Manufacturer Received04/12/2021
Supplement Dates FDA Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN CUP; UNKNOWN CUP
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight80
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