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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 702-04-50D
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
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.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
 
Event Description
Primary procedure, left hip.It was reported that after implanting the liner, it would not lock into the shell fully and had micromotion.The liner was removed and a second one was implanted with the same result.Surgeon removed the shell and liner and implanted a new shell.The new (3rd) liner locked into the shell.Inspection of the wasted liners showed a thin piece hanging circumferentially around the locking mechanism.Patient was irrigated to ensure no pieces remained in the patient.Surgery was completed successfully with a delay of approximately 15 minutes.Rep was present for and witnessed to the procedure.
 
Manufacturer Narrative
An event regarding assembly issue involving a trident ii shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: there is some slight damage noted around the outer rim of the shell.This damage is likely due to explantation of the device.There is nothing else remarkable to note.Dimensional inspection of the returned device noted the following: the device was inspected as per the igs and was found to be within spec.Functional inspection of the returned device noted the following: , due to the damage on the return liners, a functional inspection was not possible with the devices returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported 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 pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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 implanting the liner, it would not lock into the shell fully and had micromotion.The liner was removed and a second one was implanted with the same result.Surgeon removed the shell and liner and implanted a new shell.The new (3rd) liner locked into the shell.Inspection of the wasted liners showed a thin piece hanging circumferentially around the locking mechanism.Patient was irrigated to ensure no pieces remained in the patient.Surgery was completed successfully with a delay of approximately 15 minutes.Rep was present for and witnessed to the procedure.
 
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Brand Name
TRIDENTII TRITANIUM CLUSTER50D
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 Key12311971
MDR Text Key266161696
Report Number0002249697-2021-01365
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327344103
UDI-Public07613327344103
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 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number702-04-50D
Device Catalogue Number702-04-50D
Device Lot Number82948701A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
Patient Weight75
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