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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 702-04-48D
Device Problems Insufficient Information (3190); Difficult or Delayed Separation (4044)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2020
Event Type  Injury  
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Primary procedure, right hip.It was reported that the impactor bolt became stuck in the shell, and that the impactor sheared off where the handle meets the curved part of the impactor.All devices (including the shell) were removed from the patient and another shell was implanted.Surgery was completed successfully with a delay of approximately 2 minutes.Rep may be able to provide some additional patient information, otherwise confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding a disassembly issue involving a trident shell and an impactor bolt was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as product return as well as images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
 
Event Description
Primary procedure, right hip.It was reported that the impactor bolt became stuck in the shell, and that the impactor sheared off where the handle meets the curved part of the impactor.All devices (including the shell) were removed from the patient and another shell was implanted.Surgery was completed successfully with a delay of approximately 2 minutes.Rep may be able to provide some additional patient information, otherwise confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
TRIDENTII TRITANIUM 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 Key10307934
MDR Text Key199865854
Report Number0002249697-2020-01526
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327343861
UDI-Public07613327343861
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number702-04-48D
Device Catalogue Number702-04-48D
Device Lot Number76857301A
Was Device Available for Evaluation? No
Date Returned to Manufacturer07/13/2020
Initial Date Manufacturer Received 07/07/2020
Initial Date FDA Received07/22/2020
Supplement Dates Manufacturer Received01/05/2021
Supplement Dates FDA Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age76 YR
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