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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 72.5 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 72.5 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2019
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.
 
Event Description
It was reported that during a total knee arthroplasty the inner and outer packaging of the femoral component had a hole. Another femoral component was available to be used without delay or impact to the patient.
 
Manufacturer Narrative
Visual evaluation of the returned product confirmed there is a hole through the outer carton and both sterile cavities. Device history record was reviewed and no discrepancies relevant to the reported event were found. The root cause of the reported issue is attributed to transit damage. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No additional information reported.
 
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Brand NameVANGUARD CR ILOK FEM-LT 72.5
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8980159
MDR Text Key158201101
Report Number0001825034-2019-04032
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00880304449183
UDI-Public(01)00880304449183
Combination Product (y/n)N
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number183033
Device Lot NumberJ6535544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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