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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT Back to Search Results
Catalog Number 6260-9-236
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 03/13/2014
Event Type  Injury  
Event Description
It was reported that the patient's left hip was revised due to the head disassociating off of the stem.The head has been loose for undetermined amount of time and the trunnion of the stem is disfigured and a new head would not sit in place properly.Due to the age of the patient, instead of removing the stem, the surgeon cemented in a new head.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: the outside surface of the device showed signs of scratches consistent with explantation.The id of the taper had wear marks and a black residue.A material analysis has been performed.Examination with material analysis team member confirmed the id of the head taper exhibited wear marks and corrosion.This was confirmed to be consistent with similar events reported for this product and therefore further evaluation is not required.Dimensional inspection: not performed as the device was returned in a worn/used condition and therefore will not meet dimensional specifications.Functional inspection: not performed because the event occurred in vivo and therefore functionality could not be duplicated.Patient details were reviewed and no indication was found that the event was related to device design, materials, or manufacturing.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.
 
Event Description
It was reported that the patient's left hip was revised due to the head disassociating off of the stem.The head has been loose for undetermined amount of time and the trunnion of the stem is disfigured and a new head would not sit in place properly.Due to the age of the patient, instead of removing the stem, the surgeon cemented in a new head.
 
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Brand Name
V40 COCR LFIT HEAD 36MM/+5
Type of Device
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3735677
MDR Text Key21732093
Report Number0002249697-2014-01066
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2014
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 Expiration Date04/30/2010
Device Catalogue Number6260-9-236
Device Lot Number27320602
Other Device ID NumberSTERILE LOT# 0504B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/13/2014
Initial Date FDA Received04/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2005
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) Required Intervention;
Patient Age91 YR
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