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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/+5 LZO

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STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/+5 LZO Back to Search Results
Catalog Number 17-3205E
Device Problems Fracture (1260); Noise, Audible (3273)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Date 02/24/2010
Event Type  Injury  
Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported. The event was not confirmed by medical review. Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned. Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: the operative report stated, ¿a diagnosis of fracture of the right prosthetic femoral head was given. Intraoperatively multiple pieces of the fractured head were removed and a plus-5 neck sleeve was inserted with a 36 biolox head replaced on the stem. ¿ ¿no determination regarding the cause of the bilateral hip noise phenomena and the fracture of the right alumina head can be made based upon the information reviewed. If the hips were subluxating as suggested by the history and the "metallic streaking" noted in the left alumina head description this likely contributed to the clinical problems described. ¿ product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided. It was noted in the operative report that the femoral head fractured and multiple pieces were moved from the patient during the surgery. The clinician concluded that ¿no determination regarding the cause of the bilateral hip noise phenomena and the fracture of the right alumina head can be made based upon the information reviewed. If the hips were subluxating as suggested by the history and the "metallic streaking" noted in the left alumina head description this likely contributed to the clinical problems described. ¿ if the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
 
Event Description
It was reported through the filing of a lawsuit, that allegedly after implantation of the device, the patient began experiencing significant pain and discomfort in the area of the implanted device. It is further alleged that the patient has undergone premature revision surgery. Update: medical review is for the right hip revision of the primary surgery. As noted in the clinician's review, "on (b)(6) 2010 an operative report for a revision of the right acetabular liner and head describes general anesthesia and the use of the previous incision. A diagnosis of fracture of the right prosthetic femoral head was given. Intraoperatively multiple pieces of the fractured head were removed and a plus-5 neck sleeve was inserted with a 36 biolox head replaced on the stem. The alumina liner was replaced with a poly insert by uncomplicated surgery. ".
 
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Brand NameALUMINA C-TAPER HEAD 32MM/+5
Type of DeviceLZO
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
bradley curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7447444
MDR Text Key106070415
Report Number0002249697-2018-01187
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2012
Device Catalogue Number17-3205E
Device Lot Number23394601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2007
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: 04/20/2018 Patient Sequence Number: 1
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