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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 SECURFIT STEM WITH COLLAR HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 SECURFIT STEM WITH COLLAR HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problem Injury (2348)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that the patient's right hip was revised due to disassociation. Originally, shell was suspected to be loose. Intra-operatively, shell was found to be well-fixed. The metal liner was found to not be locked into the shell. The stem was also found to not be well-fixed. A size 8 securfit stem with collar, 28 +10 metal head, adm/mdm liner construct were revised to a restoration modular stem construct with another metal head and a poly liner.
 
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Brand NameSIZE 8 SECURFIT STEM WITH COLLAR
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
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key8327905
MDR Text Key135853540
Report Number0002249697-2019-00958
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 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
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: 02/11/2019 Patient Sequence Number: 1
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