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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE STEM; HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE STEM; HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Injury (2348)
Event Date 04/02/2018
Event Type  Death  
Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: unknown rejuvenate neck; cat#unknown; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
Patient was implanted with a rejuvenate on (b)(6) 2011 and she was revised on (b)(6) 2017 where she went into cardiac arrest and passed away shortly afterwards.
 
Manufacturer Narrative
An event regarding revision involving an unknown rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: review of device history records could not be performed as the reported device was not properly identified.Complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with ra 2012-067.Conclusions: it was reported that patient was revised due to unknown reasons and shortly afterwards she went into cardiac arrest and passed away.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision is considered to be under the scope of this recall.No further investigation is required.Corrective action: ncr 106450 was initiated on (b)(6) 2012 because the occurrence rate for adverse local tissue reaction (altr) specified in the risk management files for the rejuvenate modular hip system was exceeded.Given the potential risk of fretting and corrosion with these devices, voluntary product recall ra 2012-067 was issued.
 
Event Description
Patient was implanted with a rejuvenate on (b)(6) 2011 and she was revised on (b)(6) 2017 where she went into cardiac arrest and passed away shortly afterwards.
 
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Brand Name
UNKNOWN REJUVENATE STEM
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
merin grace
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7465576
MDR Text Key106651715
Report Number0002249697-2018-01254
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2018
Initial Date FDA Received04/26/2018
Supplement Dates Manufacturer Received05/28/2018
Supplement Dates FDA Received06/26/2018
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
Removal/Correction Number2249697-04/21/12-001C
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Required Intervention;
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