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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS MAHWAH UNKNOWN REJUVENATE MODULAR STEM IMPLANT Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 03/26/2012
Event Type  Injury  
Event Description

It was reported that, "the team has received verbal communication from dr (b)(6) that he has 10 pts that have a potential metal sensitivity to the rejuvenate modular stem/neck. These pts have not yet been revised. As the team has more info they will continue to provide it. ".

 
Manufacturer Narrative

An eval of the device cannot be performed as the device remained implanted in the pt and was not returned to the mfr. Add'l info pertaining to the device referenced in this report (including x-rays and medical records) was requested. Should add'l info become available, the eval summary will be submitted in a supplemental report. This is the same pt/event as mfr# 9616680-2012-00252.

 
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Brand NameUNKNOWN REJUVENATE MODULAR 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
jadwiga degrado
325 corporate dr.
mahwah, NJ 07430
2018315000
MDR Report Key2544455
MDR Text Key2606370
Report Number2249697-2012-00454
Device Sequence Number1
Product Code JDI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/26/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2012
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 Received03/26/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/17/2012 Patient Sequence Number: 1
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