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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS MAHWAH UNKNOWN REJUVENATE SIZE 7 STEM IMPLANT

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STRYKER ORTHOPAEDICS MAHWAH UNKNOWN REJUVENATE SIZE 7 STEM IMPLANT Back to Search Results
Event Date 12/16/2011
Event Type  Injury  
Event Description

It was reported that, "the pt was revised due to corrosion of the neck, stem and taper. ".

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. If additional info becomes available then it will be submitted in a supplemental report.

 
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Brand NameUNKNOWN REJUVENATE SIZE 7 STEM
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS MAHWAH
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS MAHWAH
325 corporate dr
mahwah NJ 07430
Manufacturer Contact
mrunali patel
325 corporate dr
mahwah , NJ 07430
2018315000
MDR Report Key2415100
Report Number2249697-2012-00032
Device Sequence Number1
Product CodeJDI
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/16/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/16/2011
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 TREATMENT DATA
Date Received: 01/10/2012 Patient Sequence Number: 1
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