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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR POR FMRL-LT 70; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. VANGUARD CR POR FMRL-LT 70; PROSTHESIS, KNEE Back to Search Results
Catalog Number 183072
Device Problem Delivered as Unsterile Product (1421)
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 reporting 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 identified this device did not cause or contribute to a reportable malfunction.Sterility was not compromised.Please void this submission.
 
Manufacturer Narrative
It was identified this device did not cause or contribute to a reportable malfunction.Sterility was not compromised.Please void this submission.
 
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Brand Name
VANGUARD CR POR FMRL-LT 70
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8568536
MDR Text Key143684149
Report Number0001825034-2019-01923
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K171054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number183072
Device Lot Number549300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received05/01/2019
Supplement Dates Manufacturer Received08/02/2019
Supplement Dates FDA Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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