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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 Problem Noise, Audible (3273)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 10/14/2016
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. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not available.
 
Event Description
It was reported by the attorney through the filing of a legal claim that the patient underwent a right total hip arthroplasty on (b)(6) 2007 where he was implanted with a stryker hip system. It is further alleged that the patients right hip was then revised on (b)(6) 2016 due to elevated levels of cobalt found in bloodwork and clicking.
 
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Brand NameUNKNOWN ACCOLADE II HIP 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 Key7358455
MDR Text Key103086995
Report Number0002249697-2018-00816
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2018
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: 03/21/2018 Patient Sequence Number: 1
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