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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II; HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 05/11/2017
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 al left hip revision due to loosening of components and pain.
 
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Brand Name
UNKNOWN ACCOLADE II
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
sarah smelko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6620473
MDR Text Key76941279
Report Number0002249697-2017-01800
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 Physician
Type of Report Initial
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2017
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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