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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 0° CONSTRAINED F LINER HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 0° CONSTRAINED F LINER HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
An event regarding infection involving a liner was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned; medical records received and evaluation: no medical records were received for review with a clinical consultant; device history review: could not be performed as lot code information was not provided. Complaint history review: could not be performed as lot code information was not provided. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information including operative reports, pathology reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened. The following devices were also listed in this report: 60mm tritanium revision shell; cat#unk_jr; lot#unknown; screw 1 of 3; cat#unk_jr; lot#unknown; screw 2 of 3; cat#unk_jr; lot#unknown; screw 3 of 3; cat#unk_jr; lot#unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
 
Event Description
It was reported that patient's left hip was revised due to infection (infection reported by surgeon, unknown infecting microorganism, unknown if infection clinically confirmed). A 60mm tritanium shell with 3 screws, a 0° constrained f liner, competitor stem and head were revised to a competitor construct.
 
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Brand NameUNKNOWN 0° CONSTRAINED F LINER
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 Key8204660
MDR Text Key131706555
Report Number0002249697-2018-04188
Device Sequence Number1
Product Code KWA
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 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
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 Received11/30/2018
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: 12/28/2018 Patient Sequence Number: 1
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