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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Event Date 10/13/2014
Event Type  Injury  
Manufacturer Narrative
The other device listed in this report: cat # unknown, lot # unknown, description: unknown mitch head, manufacturer: depuy. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. 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. Not available.
 
Event Description
The plaintiff alleges that she was implanted with a mitch/accolade prosthesis combination on (b)(6) 2007 and she developed symptoms of pain about a year after primary surgery, her symptoms deteriorating over the following years. High levels of cobalt and chrome were identified in her blood, leading to revision surgery on (b)(6) 2014. At revision, the plaintiff says that a pseudotumor was identified.
 
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Brand NameUNKNOWN ACCOLADE
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6790566
MDR Text Key82560771
Report Number0002249697-2017-02465
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
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 Received07/18/2017
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: 08/11/2017 Patient Sequence Number: 1
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