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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZNN TIBIAL TRAYS; TRAUMA IMPLANT
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ZIMMER BIOMET, INC. UNKNOWN ZNN TIBIAL TRAYS; TRAUMA IMPLANT Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a revision procedure of znn tibia due to unknown reasons.No additional patient consequences were reported at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined that there was no device deficiency.This was a planned revision as the patient's fracture has healed.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it was determined that there was no device deficiency.This was a planned revision as the patient's fracture has healed.The initial report was forwarded in error and should be voided.
 
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Brand Name
UNKNOWN ZNN TIBIAL TRAYS
Type of Device
TRAUMA IMPLANT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10727104
MDR Text Key212795371
Report Number0001822565-2020-03619
Device Sequence Number1
Product Code LXT
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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