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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT TRITANIUM SHELL 58MM; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT TRITANIUM SHELL 58MM; HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 05/30/2018
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that patient's left hip was revised due to an anteverted shell.A stryker shell and liner and competitor stem and head were revised to a larger stryker shell with an mdm/adm liner construct with a competitor stem and head.
 
Manufacturer Narrative
An event regarding cup malposition involving an unknown trident shell was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: no product was returned for evaluation however a photograph of the explanted devices was provided.The photograph shows the shell, liner and head.Blood is visible on the explanted product.There is damage visible on the liner.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: cup malposition in excessive anteversion has contributed to impingement between cup liner and stem neck causing instability with at least subluxations in the arthroplasty requiring revision of the cup with liner.Does the review identify any procedural related factors that contributed to the event? - cup malposition in excessive anteversion as principal failure mode does the review identify any patient related factors that contributed to the event? - this patient was reported as extremely obese with a bmi of 44 where 25 is the upper limit of normal.Surgical exposure and thereby quality of reconstruction may be impaired by morbid obesity as documented in several of the surgical reports.- soft tissue laxity due to multiple revision surgeries with recurrent dislocation in the past is clearly a secondary factor.Does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices.-product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusions: a review of the provided medical records by a clinical consultant indicated: cup malposition in excessive anteversion has contributed to impingement between cup liner and stem neck causing instability with at least subluxations in the arthroplasty requiring revision of the cup with liner.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that patient's left hip was revised due to an anteverted shell.A stryker shell and liner and competitor stem and head were revised to a larger stryker shell with an mdm/adm liner construct with a competitor stem and head.
 
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Brand Name
UNKNOWN TRIDENT TRITANIUM SHELL 58MM
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7635113
MDR Text Key112225537
Report Number0002249697-2018-01939
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Was Device Available for Evaluation? No
Date Manufacturer Received07/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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