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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 2041C-3254
Device Problems Degraded (1153); Loose or Intermittent Connection (1371); Material Integrity Problem (2978); Naturally Worn (2988)
Patient Problems Edema (1820); Hematoma (1884); Injury (2348); Osteolysis (2377); No Code Available (3191)
Event Date 01/14/2016
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The primary tha surgery was performed on (b)(6) 1997.The company of the used product is unknown.After that, the 1st revision surgery was performed on (b)(6) 2011 because of the stem loosening.Stryker products were used in the 1st revision surgery.Then, the pseudotumor, the hematoma and the bone disappearance were confirmed and 2nd revision surgery was performed on (b)(6) 2016.In the 2nd revision surgery, the bone grafting and replacement of the liner and the head were conducted.The surgeon considers the osteolysis due to the wear of the liner or the pseudotumor / hematoma due to the corrosion of the trunnion.
 
Manufacturer Narrative
An event regarding osteolysis due to the wear involving a crossfire liner was reported.Wear was confirmed following material analysis and a review by a clinical consultant confirmed osteolysis.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), the inspection noted: the devices were evaluated with the aid of stereomicroscope at magnifications up to 50x.The returned insert shows scratching, burnishing, and third-body indentation were evident on the articulating surface.Scratching, burnishing, and third-body indentations are commonly identified damage modes in uhmwpe inserts.Damage due to explantation was observed on the proximal surface of the insert.Dimensional inspection: wear analysis: a dimensional analysis was conducted on the articulating surface of the insert to quantify dimensional changes resulting from material wear and deformation.A positive impression mold of the articulating cavity was created with provil novo (vinyl polysiloxine) putty.Using an optical comparator, the linear migration of the femoral head due to wear and deformation processes was measured.The linear penetration was calculated using nominal blueprint dimensions.The measured linear penetration was 0.305 mm.This deviation corresponds to an approximate wear rate of 0.075 mm/yr based on a service lifetime of 4.08 years.A clinical study reported wear rates ranging from 0.01 ¿ 0.62 mm/yr in 240 hips from 187 patients in similar devices.A material analysis concluded: the crossfire insert was returned with in vivo service-related damages to the articulating surface, including scratching, burnishing, and third-body indentations.These are commonly identified damage modes on uhmwpe inserts.The measured linear penetration wear rate on the articulating surface was consistent with wear rates determined in clinical studies.There was no evidence of manufacturing or material defects on the device features examined.Medical records received and evaluation: a review of the provided information by a clinical consultant noted: the only available x-ray documents implantation of a long exeter revision stem with osteolysis in the lateral greater trochanteric area.A mar was performed which shows an average annual wear rate of 0,075-mm/year which is quite low.According to literature some osteolysis can be expected with annual wear rates in excess of 0,15-mm/year while below 0,10-mm/year osteolysis as a result of poly wear can be excluded as cause.As such, no relationship between the measured poly wear rate and any present osteolysis can be assumed.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a material analysis was performed and concluded: the crossfire insert was returned with in vivo service-related damages to the articulating surface, including scratching, burnishing, and third-body indentations.These are commonly identified damage modes on uhmwpe inserts.The measured linear penetration wear rate on the articulating surface was consistent with wear rates determined in clinical studies.There was no evidence of manufacturing or material defects on the device features examined.A review by a clinical consultant concluded: with the current information this case cannot be solved although as discussed poly wear and corrosion can be excluded as potential cause of the problems.More information is needed to solve this case.Further information such as additional 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.If further information becomes available this investigation will be re-opened.
 
Event Description
The primary tha surgery was performed on (b)(6) 1997.The company of the used product is unknown.After that, the 1st revision surgery was performed on (b)(6) 2011 because of the stem loosening.Stryker products were used in the 1st revision surgery.Then, the pseudotumor, the hematoma and the bone disappearance were confirmed and 2nd revision surgery was performed on (b)(6) 2016.In the 2nd revision surgery, the bone grafting and replacement of the liner and the head were conducted.The surgeon considers the osteolysis due to the wear of the liner or the pseudotumor / hematoma due to the corrosion of the trunnion.
 
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Brand Name
CROSSFIRE 10 DEG INSERT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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 Key5435368
MDR Text Key38211129
Report Number0002249697-2016-00414
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K974685
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/30/2014
Device Catalogue Number2041C-3254
Device Lot Number32275101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2016
Initial Date FDA Received02/12/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age79 YR
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