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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. N-K FLX UC XL 3 4 5 AS 13MM R; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. N-K FLX UC XL 3 4 5 AS 13MM R; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Expiration Date Error (2528)
Patient Problem No Information (3190)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Report source: event occurred in (b)(6).
 
Event Description
It was reported that during a total knee arthroplasty, the surgeon implanted a device that had been expired for approximately 9 months.The patient was informed.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The event is due to user error, as the surgeon used expired product, and no intervention has occurred.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The event is due to user error, as the surgeon used expired product, and no intervention has occurred.The initial report was forwarded in error and should be voided.
 
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Brand Name
N-K FLX UC XL 3 4 5 AS 13MM R
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8391833
MDR Text Key137870154
Report Number0001822565-2019-01032
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K070214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Model NumberN/A
Device Catalogue Number00542802313
Device Lot Number62347339
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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