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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II HIP STEM; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II HIP STEM; HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Event Date 05/06/2013
Event Type  Injury  
Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.
 
Event Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2013 and has not yet scheduled a surgery for explantation of the femoral head.It is further alleged that he suffered injuries as a result of implantation of the devices at issue and excessive levels of cobalt and chromium in his blood.
 
Manufacturer Narrative
An event regarding abnormal ion level involving an accolade ii stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: the event description from the product inquiry summary states: it was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2013 and has not yet scheduled a surgery for explantation of the femoral head.It is further alleged that he suffered injuries as a result of implantation of the devices at issue, device recall and excessive levels of cobalt and chromium in his blood.Implant records from (b)(6) 2013 verify that a v40 cocr lfit femoral head was implanted.No documentation was provided that would support injuries related to its implantation.Should additional information become available i would be happy to further this assessment.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced conclusions: a review of the provided medical records by a clinical consultant indicated: 'implant records from (b)(6) 2013 verify that a v40 cocr lfit femoral head was implanted.No documentation was provided that would support injuries related to its implantation.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with and lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2013 and has not yet scheduled a surgery for explantation of the femoral head.It is further alleged that he suffered injuries as a result of implantation of the devices at issue and excessive levels of cobalt and chromium in his blood.
 
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Brand Name
UNKNOWN ACCOLADE II HIP STEM
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
EI   NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8204470
MDR Text Key131701660
Report Number0002249697-2018-04176
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/13/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2012
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) Other;
Patient Age54 YR
Patient SexMale
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