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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS HIP KIT

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ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS HIP KIT Back to Search Results
Catalog Number 00-5150-482-01
Device Problems Leak/Splash (1354); Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2015
Event Type  malfunction  
Event Description
It was reported that the battery pack of the hip kit produced heat during surgery and the batteries leaked.Only the battery pack part was returned from the customer.The surgery was finished with an alternative device.There was no report of pt or user harm or surgical delay associated with the report.No add'l clinical info was rec'd prior to this report.
 
Manufacturer Narrative
The device was returned to the mfr; however the investigation was not completed at the time of this report.A f/u medwatch will be submitted once the investigation is complete.
 
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Brand Name
HIP KIT
Type of Device
HIP KIT
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
200 west ohio ave.
dover OH 44622
Manufacturer Contact
kathleen smith
200 west ohio ave.
dover, OH 44622
3303438801
MDR Report Key4563867
MDR Text Key15345847
Report Number1526350-2015-00035
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00-5150-482-01
Device Lot Number62714730
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/23/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/27/2015
Initial Date FDA Received02/25/2015
Was Device Evaluated by Manufacturer? No
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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