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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS MAHWAH TRITANIUM REVISION ACETABULAR IMPLANT

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STRYKER ORTHOPAEDICS MAHWAH TRITANIUM REVISION ACETABULAR IMPLANT Back to Search Results
Catalog Number 509-02-56E
Device Problem Fracture
Event Date 10/01/2009
Event Type  Injury  
Event Description

It was reported, "pt is a female who had a right total hip arthroplasty several yrs ago. It did well until approximately two yrs ago, and then she started having increasing pain and loosening of her acetabular component. One yr ago, she had revision arthroplasty with stryker acetabular system. She did well when she started having pain and limping again. She came to the clinic where failure of her screws and her cup were identified. ".

 
Manufacturer Narrative

The following associated screws were also listed in this report: gap plate screws; cat# 2080-0020; lot 9akmkd. Gap plate screws; cat# 2080-0030; lot 936mma. Gap plate screws; cat# 2080-0035; lot t9mmma. Gap plate screws; cat# 2080-0040; lot 26035001. C-taper femoral head; cat# 06-3605; lot 2jrmke. Trident tritanium hemispherical shell; cat# 509-02-56e; lot evlmae. Trident x3; cat# 643-00-36e; lot k9jmrd. At the present time it cannot be determined which, if any of these devices may have caused or contributed to the loosening of the pt's acetabular component. Additional info has been requested and if available, it will be submitted in the supplemental report.

 
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Brand NameTRITANIUM REVISION ACETABULAR
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS MAHWAH
325 corporate dr
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 Key1541959
Report Number2249697-2009-00804
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type User facility
Reporter Occupation RISK MANAGER
Remedial Action Other
Type of Report Initial
Report Date 10/12/2009,10/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/19/2013
Device Catalogue Number509-02-56E
Device LOT NumberEVLMAE
OTHER Device ID NumberSTERILE LOT#MSH0802O
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/01/2009
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer10/14/2009
Date Manufacturer Received10/16/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/21/2008
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: 11/13/2009 Patient Sequence Number: 1
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