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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 502-03-50D
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 01/07/2016
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

Patient was revised due to loosening of acetabular component.

 
Manufacturer Narrative

An event regarding loosening involving an tritanium shell was reported. The event was confirmed. Method & results: device evaluation and results: not performed as the device was not returned. Medical records received and evaluation: a review of the provided medical records by a clinical consultant concluded: "the primary harm involved is aseptic loosening of a tha acetabular implant. No obvious cause for this complication was reported. Further documentation required for completion of this assessment. " 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: a review of the provided medical records by a clinical consultant concluded that the primary harm involved is aseptic loosening of a acetabular implant. The exact cause of the event could not be determined because insufficient information was provided. No further investigation for this event is possible at this time. 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. Further information such as return of device, pre and post op xrays from the index surgery and outpatient office/clinic notes are needed to determine the root cause. If devices and/or additional information become available, this investigation will be reopened.

 
Event Description

Patient was revised due to loosening of acetabular component.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
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 Key6096818
MDR Text Key59749948
Report Number0002249697-2016-03570
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143085
Number of Events Reported1
Summary Report (Y/N)N
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 Received11/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device Catalogue Number502-03-50D
Device LOT NumberN2895D
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 Received12/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2015
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: 11/11/2016 Patient Sequence Number: 1
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