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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Insufficient Information (3190)
Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Injury (2348)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Sales rep reported reason for revision: femoral fracture right hip.
 
Manufacturer Narrative
An event regarding a periprosthetic fracture involving an unknown accolade stem was reported. The event was not confirmed. Method & results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation. -medical records received and evaluation: a review of the provided medical records indicated: "there is no evidence available in the current case to suggest that device-related issues have played a role while the discussed adverse mix of patient- and procedure-related factors should be considered more than adequate to have caused the periprosthetic fracture problem in this patient. This case is not device-related. Diagnosis: - an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture requiring revision surgery. " -device history review could not be performed as the device lot is unknown. -complaint history review could not be performed as the device lot is unknown. Conclusions: a medical review was completed and diagnosed that "an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture requiring revision surgery" further information however such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.
 
Event Description
Sales rep reported reason for revision: femoral fracture right hip.
 
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Brand NameUNKNOWN ACCOLADE II STEM
Type of DeviceHIP 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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6443204
MDR Text Key71160321
Report Number0002249697-2017-01050
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/29/2017 Patient Sequence Number: 1
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