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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 05/20/2003
Event Type  Injury  
Manufacturer Narrative
An event regarding loosening involving an unknown implant stem was reported. The event was confirmed by medical review. Method & results: product evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation. Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: " in 2003 she underwent a right total hip arthroplasty, which was aborted after the acetabular component and cement was left in the femur. She was revised one month later to a cemented polished stem and an acetabular revision. X-rays at the time is described as "femoral component. Radiolucent lines with evidence of loosening. Uncemented large acetabulum. Well-fixed". On december 3, 2009 she underwent a revision right total hip arthroplasty for a diagnosis of failed right total hip arthroplasty. No x-rays are available for review, and no primary total hip arthroplasty or first revision operative reports or list of the components implanted, no operative report for the december 3, 2009 revision, and no description of the findings or examination of any explanted components are available. In this poorly documented record and minimal clinical records, there is no indication of any clinical problems resulting from factors of faulty component design, manufacturing, or materials of any stryker product". Product history review: a review of the device history records could not be performed as no lot information was provided. Complaint history review: a complaint history review could not be performed as no lot information was provided. Conclusions: the event was confirmed by medical review. As per review of the medical review it stated " x-ray at the time is described as "femoral component. Radiolucent lines with evidence of loosening. Uncemented large acetabulum. Well-fixed". No x-rays are available for review, and no primary total hip arthroplasty or first revision operative reports or list of the components implanted, no operative report for the december 3, 2009 revision, and no description of the findings or examination of any explanted components are available. In this poorly documented record and minimal clinical records, there is no indication of any clinical problems resulting from factors of faulty component design, manufacturing, or material of any stryker product". The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Not returned to the manufacturer.
 
Event Description
It was reported by the attorney for the patient as a result of a legal claim that allegedly the trident shell loosened which required a revision. Update: x-ray at the time is described as "femoral component. Radiolucent lines with evidence of loosening. Uncemented large acetabulum. Well-fixed".
 
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Brand NameUNKNOWN FEMORAL STEM
Type of DeviceHIP 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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7659133
MDR Text Key113047809
Report Number0002249697-2018-02039
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
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 Received06/08/2018
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: 07/03/2018 Patient Sequence Number: 1
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