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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 6MM MINI; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. COMP PRIMARY STEM 6MM MINI; 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).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Event Description
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
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Brand Name
COMP PRIMARY STEM 6MM MINI
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9304807
MDR Text Key200456308
Report Number0001825034-2019-05080
Device Sequence Number1
Product Code MBF
UDI-Device Identifier00880304449770
UDI-Public(01)00880304449770
Combination Product (y/n)N
PMA/PMN Number
K060692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number113626
Device Lot Number407030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Was the Report Sent to FDA? No
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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