Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 623-10-36G
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation.A 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.
 
Event Description
It was reported that the x3 poly fit inside the trident acetabular cup, however the poly was consistently moving and did not snap into the cup.As a result, the poly would not stop rotating and was not able to be implanted.A new poly of the same size was opened, which fit the cup, and the surgery was completed without further incident.It was reported that a surgical delay of 5 minutes occurred (spent seating the poly).
 
Manufacturer Narrative
Additional info: device returned.An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device noted the following: damage consistent with implantation process.Dimensional inspection & functional inspection:not performed as the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis of the returned device noted the following: damage consistent with implantation process, based on the given information no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: material evaluation was completed and indicated the following comments: damage consistent with implantation process, based on the given information no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection and functional inspection were not performed as the reported device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Thus, the exact cause of the event could not be determined.No further investigation for this event is possible 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 the x3 poly fit inside the trident acetabular cup, however the poly was consistently moving and did not snap into the cup.As a result, the poly would not stop rotating and was not able to be implanted.A new poly of the same size was opened, which fit the cup, and the surgery was completed without further incident.It was reported that a surgical delay of 5 minutes occurred (spent seating the poly).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key8471858
MDR Text Key140622257
Report Number0002249697-2019-01496
Device Sequence Number1
Product Code LPH
UDI-Device Identifier07613327039931
UDI-Public07613327039931
Combination Product (y/n)N
PMA/PMN Number
K033716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/20/2018
Device Catalogue Number623-10-36G
Device Lot NumberV80W7L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2019
Date Manufacturer Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
-
-