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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; IMPLANT Back to Search Results
Catalog Number 6260-9-240
Device Problems Material Discolored (1170); Device Disinfection Or Sterilization Issue (2909); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2015
Event Type  malfunction  
Event Description
It was reported, "when preparing to implant the head in a primary tha, the surgeon noted that the head had a gold tint/discoloration.The surgeon wiped the device and it appeared that the discoloration partially came off.The surgeon questioned sterility, so another implant was opened.".
 
Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.
 
Manufacturer Narrative
An event regarding a discoloration involving a v40 cocr lfit head 40mm/+4 was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection was performed and a slight gold tint/discoloration was found confirming the event.The discoloration is uniform.Medical records received and evaluation: not performed as there is no indication the reported event was related to patient factors.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: review of the specification for the ion implantation of co-cr alloy bearing, ims0160 version 10, indicated in section 6.1.2, workmanship and appearance requirements, that "processed components must be uniform in color and appearance over the treated area.[.] processed component shall be free from black spots, discoloration, scratches handling damage,etc." consultation with the bbs manufacturing cell confirmed the appearance of the reported femoral head is typical of the manufacturing process and that it meets the above specification requirements.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
 
Event Description
It was reported, "when preparing to implant the head in a primary tha, the surgeon noted that the head had a gold tint/discoloration.The surgeon wiped the device and it appeared that the discoloration partially came off.The surgeon questioned sterility so another implant was opened.".
 
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Brand Name
V40 COCR LFIT HEAD 40MM/+4
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 Key4451229
MDR Text Key5388305
Report Number0002249697-2015-00192
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061434
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,Followup
Report Date 01/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2017
Device Catalogue Number6260-9-240
Device Lot NumberMLHNXL
Other Device ID NumberSTERILE LOT# MSHLJ16A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2012
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;
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