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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CITATION TMZF FEMORAL STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CITATION TMZF FEMORAL STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Corroded; Material Deformation
Event Date 03/29/2017
Event Type  Injury  
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.

 
Event Description

It was reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total hip arthroplasty on (b)(6) 2015. It is further alleged that after surgery, the plaintiff began to experience pain and difficulty walking. The patients left hip was then revised on (b)(6) 2017. "during this surgery, it was discovered that there was significant metallosis and trunnionosis in plaintiff's left hip resulting in soft tissue damage. Doctor noted corrosion of the stem head morse taper junction and terminally damaged morse taper resulting in a failed stem. ".

 
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Brand NameUNKNOWN CITATION TMZF FEMORAL STEM
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7392345
Report Number0002249697-2018-00983
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 04/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SHC
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
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

Patient TREATMENT DATA
Date Received: 04/03/2018 Patient Sequence Number: 1
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