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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; IMPLANT Back to Search Results
Catalog Number 6260-5-132
Device Problems Device Damaged Prior to Use (2284); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 09/03/2014
Event Type  malfunction  
Event Description
The sales representative reported on behalf of the customer that when the packaging for the femoral head was opened, the inside of the packaging appeared to be dirty.The customer further reported that there was no delay to surgery as another femoral head was used to complete the procedure.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding a packaging issue involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: the outer box, outer and inner tyveks and blisters and device were returned.There was evidence of damage to the outer box, consistent with rough handling.Both the inner tyvek and blister and outer tyvek and blister were returned unopened and when they were peeled back, there was evidence of a complete seal on both.When the tyveks were peeled back, scuffing was noted on the outside of the inner blister and the inside of the outer blister, in an area under where the device sat but no scuffing was present on the inside of the inner blister where the device was.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the root cause was most likely a combination of rough handling of the device and the femoral head packaging part in the inner blister.The femoral head packaging part can weigh on the inner blister, this may have been aggravated by rough handling, creating friction between the outside inner blister and the inner outside blister and causing the observed scuffing.The device was packed as per assembly drawing, which matches the bill of materials package design that was ship tested.This product was ship tested for package design and met the acceptance criteria.There was no patient risk associated with this event and no manufacturing issues were identified.
 
Event Description
The sales representative reported on behalf of the customer that when the packaging for the femoral head was opened, the inside of the packaging appeared to be dirty.The customer further reported that there was no delay to surgery as another femoral head was used to complete the procedure.
 
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Brand Name
32MM STD V40 TAPER VIT HEAD
Type of Device
IMPLANT
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 Key4128359
MDR Text Key4937096
Report Number0002249697-2014-03673
Device Sequence Number1
Product Code LWJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K993601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/04/2014
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 Date12/31/2018
Device Catalogue Number6260-5-132
Device Lot Number46337604
Other Device ID NumberSTER. LOT 1312MCM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/12/2014
Initial Date FDA Received09/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2013
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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