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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 2; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 2; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The product was been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a hip procedure, the surgeon was evaluating a new stem and found that it did not fit as expected.The component was removed and not fully implanted.The surgery was completed with a different product.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon receipt of additional information, 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 9613350.
 
Event Description
Upon receipt of additional information, 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 9613350.
 
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Brand Name
AVENIR CMPL HA STD NC SIZE 2
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9563587
MDR Text Key174124049
Report Number0001822565-2020-00106
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K182048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number574101020
Device Lot Number2964875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight79
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