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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT 52MM HEMISPHERICAL SHELL; HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT 52MM HEMISPHERICAL SHELL; HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Injury (2348)
Event Date 11/09/2018
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding loosening involving an unknown trident shell 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 lot details, operative 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.Device not available.
 
Event Description
It was reported that patient's right hip was revised due to rotation of the shell after patient complaint of pain.Shell was found to be in a vertical position.A 52 mm trident hemispherical shell and liner were revised to a 60 mm titanium revision shell and liner.Rep reported that x-rays, medical records, and additional information are not available.
 
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Brand Name
UNKNOWN TRIDENT 52MM HEMISPHERICAL SHELL
Type of Device
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
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8141375
MDR Text Key129585302
Report Number0002249697-2018-03938
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 Physician
Type of Report Initial
Report Date 12/07/2018
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_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2018
Initial Date FDA Received12/07/2018
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
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