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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

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STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES Back to Search Results
Catalog Number 2101-0200
Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2016
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It is reported by the surgeon of the hospital, that although she firmly screwed the trident acetabular shell, it loosened from the impactor during driving. A replacement was available.
 
Manufacturer Narrative
An event regarding excessive thread length involving a universal impactor/positioner was reported. The event was not confirmed. Method & results: device evaluation could not be performed as the subject device was not returned. Medical records received and evaluation: no medical records were received for review with a clinical consultant. Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. Complaint history review: there has been one other similar event for lot smm9a09. Pr was opened to investigate an assembly issue. Conclusions: the investigation determined that the reported failure has been previously investigated under pr. Nc pr was opened to further investigate the observed non-conformance.
 
Event Description
It is reported by the surgeon of the hospital, that although she firmly screwed the trident acetabular shell, it loosened from the impactor during driving. A replacement was available.
 
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Brand NameUNIVERSAL IMPACTOR/POSTIONER
Type of DeviceHIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5396084
MDR Text Key37239621
Report Number0002249697-2016-00207
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
PMA/PMN Number
K151264
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 01/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2014
Device Catalogue Number2101-0200
Device Lot NumberSMM9A09
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 Received03/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/28/2016 Patient Sequence Number: 1
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