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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIDENT SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIDENT SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_JR
Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 10/29/2021
Event Type  Injury  
Event Description
It was reported that the patient's right hip was revised due to trunnionosis and dissociation of the femoral head from the stem.Surgeon also reported that the acetabular shell was in a neutral version.The entire hip construct was revised.Rep was not present for explantation of the liner and does not know if there are any allegations against it.Rep confirmed that pictures can be provided, and that otherwise, no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
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
It was reported that the patient's right hip was revised due to trunnionosis and dissociation of the femoral head from the stem.Surgeon also reported that the acetabular shell was in a neutral version.The entire hip construct was revised.Rep was not present for explantation of the liner and does not know if there are any allegations against it.Rep confirmed that pictures can be provided, and that otherwise, no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event: an event regarding malposition involving an unknown trident shell was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "materials.Reviewed: undated/unlabeled: right ap hip x-ray.Stem appears stable in bone.Trunnion obviously deformed/worn, femoral head dissociated from the stem, acetabular shell appears stable.Confirmation: disassociation of a femoral head from a stem may be confirmed (x-rays undated and unlabeled).A revision surgery cannot be confirmed without additional records.Root cause: the root cause of the severe trunnionosis and wear cannot be confirmed without implant lot numbers, additional medical records." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the reported of the malposition of the shell was not confirmed by review of the provided x-ray by a clinical consultant.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, additional pre- and post-operative x-ray views 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
UNKNOWN_TRIDENT SHELL
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12844250
MDR Text Key281020369
Report Number0002249697-2021-01935
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/18/2022
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
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/19/2021
Supplement Dates Manufacturer Received02/01/2022
Supplement Dates FDA Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age76 YR
Patient SexMale
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