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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIDENTII TRITANIUM CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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TRIDENTII TRITANIUM CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 702-04-50D
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/11/2021
Type of Reportable Event Serious Injury
Additional 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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
 
Event or Problem Description
It was reported the patient's right hip was revised.Original reason for revision was dissociation of the liner from the shell.Intra-operatively, the following were noted: deformation of the liner, metallosis due to impingement of the stem on the shell, and the surgeon reported the stem was too small for the patient's anatomy (rep confirmed there are no allegations against the femoral stem's actual vs.Reported size).The stem, head, and liner were revised.Rep provided primary and revision usage and an explant picture, and confirmed that no further information will be released by the hospital or surgeon.
 
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Brand Name
TRIDENTII TRITANIUM CLUSTER50D
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MDR Report Key12754749
Report Number0002249697-2021-01835
Device Sequence Number1454313
Product Code LPH
UDI-Device Identifier07613327344103
UDI-Public07613327344103
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K171768
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/04/2021
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? No
Operator of Device Health Professional
Device Expiration Date03/31/2024
Device Model Number702-04-50D
Device Catalogue Number702-04-50D
Device Lot Number70110101A
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/11/2021
Initial Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/29/2019
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
Patient Weight106
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