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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 623-00-36E
Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Pain (1994); Depression (2361); Ambulation Difficulties (2544); Joint Laxity (4526)
Event Date 12/13/2013
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.Device evaluated by manufacturer? not returned.
 
Event Description
As per patient, she had a right tha done (b)(6) 2013 about four months after surgery she couldn't walk during pt, she started to experience pain, has no balance.Patient has to use a walker.Patient would like to know if her implants are part of a recall.Patient is seeking assistance with revision surgery.
 
Manufacturer Narrative
An event regarding instability involving a trident liner 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 remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: based upon the information given to me and the supporting documentation i cannot confirm that this event did occur.As to the root cause of the event, this cannot be determined since i cannot discern any adverse impact on the patient related to the episode of care.X-rays and office notes would be helpful in this regard.Taking into consideration all of the material subsequently submitted, it does not change my previously stated opinion.The most important information not provided are patient¿s postoperative office notes by and postoperative x-rays taken with proper positioning.It is well-known that patients who have been given an increased offset following total hip replacement can experience symptoms consistent with lateral hip pain and trochanteric bursitis.I am not saying that this has happened in this case, but further documentation, notes and x-rays would be needed in order to make a final appraisal.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: 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 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.The patient inquired if the device was part of a recall,.It can be confirmed that the devices were not part of a recall.
 
Event Description
As per patient, she had a right tha done (b)(6) 2013 about four months after surgery she couldn't walk during pt, she started to experience pain, has no balance.Patient has to use a walker.Patient would like to know if her implants are part of a recall.Patient is seeking assistance with revision surgery.
 
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Brand Name
TRIDENT 0 X3 INSERT 36MM ID
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11124392
MDR Text Key225324401
Report Number0002249697-2021-00041
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/16/2021
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
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Catalogue Number623-00-36E
Device Lot NumberMMJV16
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received01/06/2021
Supplement Dates Manufacturer Received03/23/2021
Supplement Dates FDA Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2013
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) Other;
Patient Age70 YR
Patient Weight82
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