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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Corroded (1131)
Patient Problems Pain (1994); Seroma (2069); Weakness (2145); Injury (2348); Reaction (2414)
Event Date 06/26/2017
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
It was reported that a revision was performed on a left total hip due to pain and weakness in the hip. Doctor noted that when opening patient's hip, he immediately found large amounts of fluid and abnormal tissue which were both sent on to pathology (pathology identified the abnormal tissue as a pseudo-tumor). Doctor also stated that there was corrosion inside the femoral head and on the trunnion, and that the levels of chromium and cobalt were elevated. Doctor cleaned the trunnion and applied a new sleeve over the trunnion with a delta head and an mdm liner & insert. There were no delays in surgery.
 
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Brand NameUNKNOWN ACCOLADE 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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6736366
MDR Text Key80810617
Report Number0002249697-2017-02264
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
Report Date 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
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 Received06/26/2017
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: 07/24/2017 Patient Sequence Number: 1
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