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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MICRO TAPERLOC COMPLETE PPS TYPE 1; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. MICRO TAPERLOC COMPLETE PPS TYPE 1; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).
 
Event Description
It was reported that when the customer opened the sterilization packaging of this product, a cushioning material of white polyurethane in the sterilization packaging tray and the polyethylene bag of product was also damaged.Attempts have been made and no further information has been provided.
 
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 : 3002806535 -2019 - 00848.K.
 
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 : 3002806535 -2019 - 00848.
 
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Brand Name
MICRO TAPERLOC COMPLETE PPS TYPE 1
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8655024
MDR Text Key146539053
Report Number0001825034-2019-02326
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K120030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number51-145110
Device Lot Number3892093
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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