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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX V40 SLEEVE -4MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

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STRYKER ORTHOPAEDICS-MAHWAH UNITRAX V40 SLEEVE -4MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS. Back to Search Results
Catalog Number 6942-6-060
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2015
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
 
Event Description
Accolade c unitrax sleeve did not cold weld on the trunnion and was spinning and could not get sleeve off of head.
 
Manufacturer Narrative
An event regarding sit/fite issue involving a unitrax sleeve was reported.The event was not confirmed.Method & results: device evaluation and results: the sleeve and the head were returned assembled together and cannot be disassembled.The portion of the sleeve that is visible within the head is visually unremarkable.No further analysis of the devices was possible as they cannot be disassembled.Medical records received and evaluation: a review by a clinical consultant concluded that it is not possible to establish a root cause of failure due to lack of adequate information.Device history review: the reported device was manufactured into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined based on the information available.The sleeve and the head were returned assembled together and cannot be disassembled.The portion of the sleeve that is visible within the head is visually unremarkable.A review by a clinical consultant concluded that it is not possible to establish a root cause of failure due to lack of adequate information.No further investigation for this event is possible at this time.
 
Event Description
Accolade c unitrax sleeve did not cold weld on the trunnion and was spinning and could not get sleeve off of head.
 
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Brand Name
UNITRAX V40 SLEEVE -4MM
Type of Device
HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5235369
MDR Text Key31830195
Report Number0002249697-2015-03904
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue Number6942-6-060
Device Lot Number50423301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2015
Initial Date FDA Received11/19/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2014
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) Other;
Patient Age81 YR
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