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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 6120-0-737 ACCOLADE 2 HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 6120-0-737 ACCOLADE 2 HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 06/12/2017
Event Type  Injury  
Manufacturer Narrative
An event regarding periprosthetic fracture involving an unknown accolade stem was reported. The event was 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 x-ray by a clinical consultant indicated. "this would leave an external trauma of the patient as the most likely cause of the problem. Even though trauma was not reported, both timing and type of fracture are thus consistent with an external trauma of the patient at a time when bone ingrowth fixation was already completed. " "procedure-related factors: none. Patient-related factors: patient trauma. Device-related factors: none. Diagnosis: a traumatic overload condition has contributed to a periprosthetic fracture around the accolade ii stem requiring revision. " 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: the exact cause of the event could not be determined nor the root cause confirmed however a review of the medical records by a clinical consultant indicated that "this would leave an external trauma of the patient as the most likely cause of the problem. Even though trauma was not reported, both timing and type of fracture are thus consistent with an external trauma of the patient at a time when bone ingrowth fixation was already completed. " further information such as device details, return of device, operative reports, & 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
Patient presented with a periprosthetic fracture. Restoration modular was used as a replacement.
 
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
Patient presented with a periprosthetic fracture. Restoration modular was used as a replacement.
 
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Brand NameUNKNOWN 6120-0-737 ACCOLADE 2
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 Key6698068
MDR Text Key251905214
Report Number0002249697-2017-02140
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 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
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 Received08/10/2017
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: 07/10/2017 Patient Sequence Number: 1
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