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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_UNKNOWN ACCOLADE TMZF HIP STEM UNKNOWN HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_UNKNOWN ACCOLADE TMZF HIP STEM UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problems Corroded (1131); Material Deformation (2976)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 02/15/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's right hip was revised due to pain and elevated cobalt levels. Intra-operatively, surgeon noted corrosion inside the femoral head. Head and liner were revised to an mdm/adm liner construct with a ceramic head and sleeve. Rep provided an explant picture and x-ray and reported that no further information would be released by the hospital or surgeon.
 
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Brand NameUNKNOWN_UNKNOWN ACCOLADE TMZF HIP STEM
Type of DeviceUNKNOWN 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
evelyn ryan
raheen business park
limerick NA
61498200
MDR Report Key8422351
MDR Text Key138888278
Report Number0002249697-2019-01341
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 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
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 Received02/15/2019
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: 03/14/2019 Patient Sequence Number: 1
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