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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZUK HIGH FLEX ARTICULAR SURGACE
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ZIMMER, INC. ZUK HIGH FLEX ARTICULAR SURGACE Back to Search Results
Catalog Number 00584203210
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2014
Event Type  malfunction  
Event Description
It is reported that after the device was implanted it was discovered that the implant had an expiry date of december 2012.
 
Manufacturer Narrative
The labeling was reviewed and found to clearly indicate an expiry date of 12/2012.The device history records were reviewed and indicate the device was manufactured, inspected, and packaged to specifications.This is the first complaint recorded for this part number, regardless of lot number.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify and evidence of product contribution to the reported problem.
 
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Brand Name
ZUK HIGH FLEX ARTICULAR SURGACE
Manufacturer (Section D)
ZIMMER, INC.
po box 708
warsaw IN 46581 070
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key3817530
MDR Text Key4397064
Report Number1822565-2014-00428
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2012
Device Catalogue Number00584203210
Device Lot Number60238179V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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