Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEMORAL HEAD 32MM DIA. -5; HIP IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH FEMORAL HEAD 32MM DIA. -5; HIP IMPLANT Back to Search Results
Catalog Number 465541
Device Problems Break (1069); Fracture (1260); Device Abrasion From Instrument Or Another Object (1387); Material Integrity Problem (2978)
Patient Problems Pain (1994); Injury (2348)
Event Date 06/21/2016
Event Type  Injury  
Manufacturer Narrative
The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
 
Event Description
It is reported by the nurse of the hospital, that the femur head broke with traces of abrasion.Exchange of the shaft, head, and the inlay of the socket.Sales rep confirmed via e-mail that this is a revision case.
 
Manufacturer Narrative
The device was returned and evaluated.An event regarding a crack/fracture involving a ceramic head was reported.The event was confirmed following visual inspection.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).The report noted the following: approximately 80% of the head was returned.Secondary chipping was observed on a majority of the fracture surfaces.The reconstruction shows a generally longitudinal fracture pattern.This type of pattern is created by hoop stresses generated by the wedge-effect of the stem trunnion.The fracture pattern is consistent with the application of the device.Examination of the machined tapered surfaces showed whitening of the ceramic tapered surface.This whitened surface was consistent with the phase transformation of the zirconia from the tetragonal phase to the monoclinic phase, as reported in the clinical literature.This phase transformation can cause internal stresses in the base material.The observed fracture morphology is consistent with an overload fracture, with the crack propagating outward from the taper.This direction has been verified by the observation of a fracture origin on the female taper surface.A material analysis has been performed.The report concluded: the ceramic head was fractured.Based on the above, the highly stressed region of the ceramic machined tapered surface had undergone a phase transformation, which may have an effect on the structural integrity of the material.However, clinical and patient history may also play a role in the survivorship of any implant.This specific implant is no longer available for sale.Damage, consistent with contact from the stem trunnion and head fragments after the head fractured, was observed on the insert.Medical records received and evaluation: a review by a clinical consultant noted: the are records of primary arthroplasty 1999 that confirm no issues or complications while the revision surgery report of 2016 confirms the femoral head fracture but provides no details about the conditions surrounding the fracture event nor information that help understand the failure mechanism.It just deals with the technicalities of component exchange to non-stryker devices (again s&n).There is a mar that also confirms the problem including some phase changes in the material but otherwise has no clues about the specific failure mechanism.Edge loading caused by component malposition is a frequent issue with ceramic head fractures but unfortunately no x-rays are available to check this.Because the provided info also doe snot help to understand the failure mode.Conclusions: a review a by a clinical consultant concluded: it is not possible to solve the case with the current information.Relevant x-rays are required at minimum.Additional information, including correct device lot # details, operative reports, patient history, x-rays, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It is reported by the nurse of the hospital, that the femur head broke with traces of abrasion.Exchange of the shaft, head, and the inlay of the socket.Sales rep confirmed via e-mail that this is a revision case.
 
Manufacturer Narrative
This device was determined to be under the scope of a recall.Howmedica osteonics issued a product recall in 2001 relating to the potential breakage of zirconia heads.
 
Event Description
It is reported by the nurse of the hospital, that the femur head broke with traces of abrasion.Exchange of the shaft, head, and the inlay of the socket.Sales rep confirmed via e-mail that this is a revision case.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FEMORAL HEAD 32MM DIA. -5
Type of Device
HIP 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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5808103
MDR Text Key49954252
Report Number0002249697-2016-02380
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Nurse
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number465541
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2243265-08/16/01-003R
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-