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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-10-36E
Device Problems Device Inoperable (1663); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Scratched Material (3020); Noise, Audible (3273)
Patient Problems Injury (2348); No Information (3190)
Event Date 07/23/2015
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
Surgeon has done a thr 6 weeks ago.Everything was fine at that time but when patient started walking, she was getting a cluck sound in the prosthesis.She went back to the surgeon, surgeon got the x-ray done and found that the insert's locking mechanism couldn't sustain.The next day surgeon operated the patient and changed the insert.
 
Manufacturer Narrative
An event regarding the "insert¿s locking mechanism couldn¿t sustain" (disassociation) involving a trident liner was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a review of the provided information by a clinical consultant diagnosed that "incomplete trident liner seating in the shell during assembly in primary arthroplasty has allowed movement of the liner in and out of the shell during walking generating a ¿clucking¿ vacuum sound and subluxation appearance on x-ray." the clinician also indicated that there was no evidence of device related factors were responsible for the event.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: a medical review indicated that there was no evidence of a device related issue.The exact cause of the event however could not be determined because insufficient information was provided.Additional information such as device return are needed to fully investigate the event.If further relevant information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
Surgeon has done a thr 6 weeks ago.Everything was fine at that time but when patient started walking, she was getting a cluck sound in the prosthesis.She went back to the surgeon, surgeon got the x-ray done and found that the insert's locking mechanism couldn't sustain.The next day surgeon operated the patient and changed the insert.
 
Manufacturer Narrative
The device was returned.Device evaluation and results: substantial damage was noted on the returned trident liner.The locking mechanism was scratched and worn around the locking mechanism of the device.Conclusions: a medical review indicated that there was no evidence of a device related issue.The exact cause of the event however could not be determined because insufficient information was provided.Additional information such as device return are needed to fully investigate the event.If further relevant information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
Surgeon has done a thr 6 weeks ago.Everything was fine at that time but when patient started walking, she was getting a cluck sound in the prosthesis.She went back to the surgeon, surgeon got the x-ray done and found that the insert¿s locking mechanism couldn't sustain.The next day surgeon operated the patient and changed the insert.
 
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Brand Name
TRIDENT 10° X3 INSERT 36MM ID
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-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5041472
MDR Text Key24520371
Report Number0002249697-2015-02829
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Followup,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Catalogue Number623-10-36E
Device Lot Number48623401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2014
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;
Patient Age31 YR
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