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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 623-00-36D
Device Problem Insufficient Information (3190)
Patient Problems Injury (2348); Insufficient Information (4580)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: delta c-taper head 36mm +5; 18-3605;63451401; ti sleeve for alumina head; 17-0000e; d52ak3.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
 
Event Description
Procedure: the patient underwent right total hip arthroplasty (b)(6) 2020.Patient was diagnosed with a dvt received anticoagulation and developed a hematoma, underwent right total hip revision (b)(6) 2020.Head and poly exchanged.Reported in cors per 8714hip.Patient had a second debridement and irrigation on (b)(6) 2020.Head and poly exchanged again.
 
Event Description
Procedure: the patient underwent right total hip arthroplasty (b)(6) 2020.Patient was diagnosed with a dvt received anticoagulation and developed a hematoma, underwent right total hip revision (b)(6) 2020.Head and poly exchanged.Reported in cors per 8714hip.Patient had a second debridement and irrigation on (b)(6) 2020.Head and poly exchanged again.
 
Manufacturer Narrative
Reported event: an event regarding patient factors and further revision is reported involving trident liner.The event was confirmed based on medical review, but no device specific failure modes were identified or confirmed.Method & results: product evaluation and results: product inspection - 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: adverse event identified: hematoma and infection resulting in multiple i and d procedures and ultimately in resection arthroplasty and placement of an off-labelled antibiotic loaded device in the right hip.Hazards: none clearly related to implant.Conclusion of assessment: the hematoma and infection were confirmed.The medically compromised patient underwent one documented i and d with a head and liner exchange.The second i and d with head and liner exchange and the resection arthroplasty were confirmed solely from the pi reports.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding patient factors and further revision is reported involving trident liner.The event was confirmed based on medical review, but no device specific failure modes were identified or confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
TRIDENT 0 DEG INSERT 36MM
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 Key10459225
MDR Text Key204547781
Report Number0002249697-2020-01748
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327025309
UDI-Public07613327025309
Combination Product (y/n)N
PMA/PMN Number
K062419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/20/2020
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 Model Number623-00-36D
Device Catalogue Number623-00-36D
Device Lot Number4D6P4H
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/03/2020
Initial Date FDA Received08/27/2020
Supplement Dates Manufacturer Received10/27/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
Patient Weight88
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