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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

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STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE Back to Search Results
Catalog Number 2051-2046
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 02/15/2010
Event Type  Injury  
Manufacturer Narrative
An event regarding poly wear involving a securfit shell was reported. A clinical review confirmed the event. Device evaluation and results: a visual, dimensional, functional and material analysis inspection was not performed as the device was not returned for evaluation. Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: "the description of the acetabular component as "more vertical than normal" would suggest an inherently unstable hip that, after some poly wear, dislocated. It was noted on (b)(6) 2001 (four months status-post primary total hip) that the hip was popping in and out of place. The first revision done, in which a constrained liner was not available in the operating room, resulted in persistent instability causing the subsequent revision to a constrained liner two months later. During this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell. There is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation. " device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there has been one other event for the lot referenced, however, it is for the same patient. A medical review confirmed that the wear of the liner is a result of the shell positioning as noted "more vertical than normal" and "during this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell". No further investigation is required at this time. If additional relevant information becomes available, this investigation will be reopened. Not returned.
 
Event Description
Per medical review: "on (b)(6) 2010 a revision of the right total hip arthroplasty with exchange of the poly insert and femoral head was performed for a diagnosis of poly wear right hip. " medical review notes operative report dated (b)(6) 2010 states: "acetabulum may be a little more vertical than normal".
 
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Brand NameSECUR-FIT HA PSL CUP/CLUSTR SHELL 46MM
Type of DeviceHIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7903852
MDR Text Key121562496
Report Number0002249697-2018-03019
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2051-2046
Device Lot Number53099801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2000
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: 09/24/2018 Patient Sequence Number: 1
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