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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 500-03-54E
Device Problem Insufficient Information
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

Surgeon commented that cup was loose based on bone scan and subsequent easy removal of cup with no bone on/in growth.

 
Manufacturer Narrative

An event regarding loosening involving an tritanium shell was reported. The event was not confirmed. Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned. -medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review. -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced. Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided. A capa trend analysis was conducted for the reported failure mode and concluded loosening may result from other factors not necessarily related to the device. No further investigation for this event is possible at this time. Further information such as return of device, operative reports, clinical and past medical history, additional x-rays are needed to investigate this event further. If devices and/or additional information become available, this investigation will be reopened.

 
Event Description

Surgeon commented that cup was loose based on bone scan and subsequent easy removal of cup with no bone on/in growth.

 
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Brand NamePRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
cindy chuhinko
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key6105467
Report Number0002249697-2016-03621
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number500-03-54E
Device LOT Number808HR0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/20/2015
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: 11/16/2016 Patient Sequence Number: 1
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