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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS CORK UNKNOWN RIGHT REJUVENATE/ABG II HIP NECK IMPLANT

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STRYKER ORTHOPAEDICS CORK UNKNOWN RIGHT REJUVENATE/ABG II HIP NECK IMPLANT Back to Search Results
Event Date 09/01/2010
Event Type  Injury  
Event Description

It was reported that patient complains of pain since the surgery. Patient stated that she has attended rehab and pain management, but nothing has helped her. Patient has rec'd recall letter. Patient will look into another surgeon as her primary surgeon is no longer at that hospital.

 
Manufacturer Narrative

The catalog and lot number along with the device were not provided for investigation. The event is confirmed. A voluntary recall (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices. The reported event is considered to be under the scope of this recall.

 
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Brand NameUNKNOWN RIGHT REJUVENATE/ABG II HIP NECK
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS CORK
carrigtwohill n/a
cork
EI 
Manufacturer (Section G)
STRYKER ORTHOPAEDICS CORK
carrigtwohill n/a
ida industrial estate
cork
EI 
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key3569478
Report Number9616680-2013-90289
Device Sequence Number1
Product CodeJDI
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 12/18/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2014
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? No
Date Manufacturer Received12/18/2013
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: 01/03/2014 Patient Sequence Number: 1
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