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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII HEMI CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII HEMI CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 702-11-48D
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Primary procedure, left hip.It was reported that after impacting the shell, the impacting bolt was cold-welded into the shell and could not be removed.The construct was removed and another shell implanted with a screw.Surgery was completed successfully with a delay of approximately 10 minutes.The cold-welded construct is allegedly available for return.The rep provided the usage sheet showing the wasted shell and reported that no further information will be available.
 
Manufacturer Narrative
Reported event: an event regarding disassembly issue involving a trident shell was reported.The event was not confirmed.Method & results.Product evaluation and results: visual inspection of the returned device noted the following: examination of returned device indicated that the bolt was tightly fastened to the shell as described by the event details.Failure mode is confirmed.The device was separated for material analysis.Material analysis: damage consistent with contact against a hard object was observed on the distal surface and female threads of the shell.X-ray fluorescence spectroscopy showed the shell base material is consistent with an astm f136 alloy, which is consistent with the drawing.Debris was observed on the distal surface and female threads.Energy dispersive spectroscopy showed the debris is consistent with an oxide, the decontamination process, material transfer from the bolt, biological material, and the base material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative report as well as additional information from the user are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Primary procedure, left hip.It was reported that after impacting the shell, the impacting bolt was cold-welded into the shell and could not be removed.The construct was removed and another shell implanted with a screw.Surgery was completed successfully with a delay of approximately 10 minutes.The cold-welded construct is allegedly available for return.The rep provided the usage sheet showing the wasted shell and reported that no further information will be available.
 
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Brand Name
TRIDENTII HEMI CLUSTER48D
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 Key9538435
MDR Text Key185952488
Report Number0002249697-2020-00011
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327380903
UDI-Public07613327380903
Combination Product (y/n)N
PMA/PMN Number
K171768
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number702-11-48D
Device Catalogue Number702-11-48D
Device Lot Number65313803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Date Manufacturer Received03/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age46 YR
Patient Weight80
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