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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 six potential patients with metal sensitivity from the rejuvenate modular stem and neck. The product team does not have any more information and will need to reach out to the local sales branch for more data. ¿.

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer. Additional information pertaining to the device referenced in this report (including x-rays and medical records) was requested. Should additional information become available, the evaluation summary will be submitted in a supplemental report. This is the same patient/event as mfr # 9616680-2012-00267.

 
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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 Key2544462
MDR Text Key2607723
Report Number2249697-2012-00463
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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