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

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.

• 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 Key: 7465576
• MDR Text Key: 106651715
• Report Number: 0002249697-2018-01254
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/26/2018
• 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 Number: 2249697-04/21/12-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention