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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN - ACCOLADE TMZF STEM UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); Reaction (2414)
Event Date 02/11/2019
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 the patient's hip was revised due to dislocation of the head from the liner. Additionally, the surgeon reported the presence of metallosis. An lfit v40 head and 36g poly liner were revised to a constrained liner with ceramic head and sleeve. The stem was not revised. Rep provided explant pictures and reported that x-rays, medical records, and additional information are not available due to hospital policy.
 
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Brand NameUNKNOWN - ACCOLADE TMZF 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
anna ryan
raheen business park
limerick NA
61498200
MDR Report Key8411970
MDR Text Key138521152
Report Number0002249697-2019-01296
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
Reporter Occupation
Type of Report Initial
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
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 Received02/11/2019
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: 03/12/2019 Patient Sequence Number: 1
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