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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD PS OPEN INTL FEMORAL RIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VANGUARD PS OPEN INTL FEMORAL RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); No Information (3190)
Event Date 07/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: biomet cc cruciate tray 67mm catalog # 141232 lot # unknown, vngd ps tib brg 14x63/67mm catalog # 183624 lot # unknown, series a pat thn 28 3 peg catalog # 184782 lot # unknown. Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001825034-2020-00801. Product location is unknown.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was revised due to loosening of femoral and tibial prosthesis. Attempt for further information has been made, but no further information has been provided.
 
Manufacturer Narrative
Concomitant medical products: cobalt mv bone cement 40gm b catalog # 402438 lot # 863050. Reported event was unable to be confirmed due to limited information received from the customer. Device was not returned. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr: 0001825034 - 2020 - 01675.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameVANGUARD PS OPEN INTL FEMORAL RIGHT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9739338
MDR Text Key189310497
Report Number0001825034-2020-00800
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Type of Report Initial,Followup,Followup,Followup
Report Date 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number183106
Device Lot Number061960
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/21/2020 Patient Sequence Number: 1
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