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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Toxicity (2333)
Event Date 11/07/2013
Event Type  Injury  
Event Description
It was reported that there was a removal of a head and liner due to high ion levels.Stem stayed in.
 
Manufacturer Narrative
Catalogue number unknown at this time.Device description reported as an unknown accolade stem.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information (including x-rays and medical records) has been requested, but not made available.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.
 
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Brand Name
UNKNOWN_RECONSTRUCTIVE_PRODUCT
Type of Device
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
jadwiga degrado
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3603273
MDR Text Key4063654
Report Number0002249697-2014-00243
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 Other,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/07/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_REC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2014
Initial Date FDA Received02/03/2014
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) Required Intervention;
Patient Age72 YR
Patient Weight82
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