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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-10-32D
Device Problems Packaging Problem (3007); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
Review of the product history records indicate 31 devices were manufactured and accepted into final stock on (b)(6) 2017 with no reported relevant discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that as they opened up the trident poly liner, they noticed a sticky residue on the packaging and that this appears to be on paper layer which is facing outwards away from the implant.They opened a second, third and 4th implant of the same lot number and noticed the residue again.The case case was completed using a 5th implant.There were a few minutes delay while alternative implants were opened.The sales rep was not in the case.
 
Event Description
The customer reported that as they opened up the trident poly liner, they noticed a sticky residue on the packaging and that this appears to be on paper layer which is facing outwards away from the implant.They opened a second, third and 4th implant of the same lot number and noticed the residue again.The case case was completed using a 5th implant.There were a few minutes delay while alternative implants were opened.The sales rep was not in the case.
 
Manufacturer Narrative
Reported event: an event regarding glue reside on the inner blister involving a trident insert was reported.The event was confirmed by product inspection.Method & results: product evaluation and results: the inner blister was returned with the box, ifu and device however, the tyvek sheet was not returned.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: 4 other events were reported for the lot indicated.Conclusions: the event for glue residue on the inner blister was confirmed by product inspection.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.Corrective action/preventive action: an nc was created for tyvek sheet residue on inner blister lid.The nc noted, ¿the retainer within the inner sealed blister showed a white residue which is characterized as a glue-like substance (tyvek residue) on the retainer.The quality monitoring and post market surveillance team completed a fourier-transform infrared spectroscopy (ftir) test and confirmed that the substance is coming from the tyvek.The white substance is fixed on the retainer (no loose particulates) and, therefore, no substance would be in contact with the implant.The visual defect also does not affect the integrity of the sterile barrier system (sbs).Therefore, the sbs still meets its intent from a seal strength and seal integrity perspective and maintains the product sterility within the package.In the event that the sealing process creates this glue-like substance defect on the retainer, this defect would be even more noticeable by the or staff once the inner blister was opened.Per ifu 4350, ¿the packaging of all sterile products should be inspected for flaws in the sterile barrier before opening.In the presence of such a flaw, the product must be assumed nonsterile.¿.
 
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Brand Name
TRIDENT 10° X3 INSERT 32MM ID
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8043896
MDR Text Key128212117
Report Number0002249697-2018-03634
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039849
UDI-Public07613327039849
Combination Product (y/n)N
PMA/PMN Number
K033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue Number623-10-32D
Device Lot NumberN049WT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2018
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
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