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 ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
  • 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 ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC Back to Search Results
Catalog Number 625-0T-28D
Device Problems Break (1069); Degraded (1153); Fracture (1260)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
 
Event Description
A hospital representative reported the following event : "we received a declaration of material vigilance from the orthopaedic block of our institution, which had to intervene to change a trident ceramic insert in a patient who had been wearing a hip replacement for 13 years.It is an implant of reference (b)(4) and lot number u5570402 or 433475g ceramic insert broken inside the liner of the cotyle.Presence of metallosis".
 
Event Description
A hospital representative reported the following event : "we received a declaration of material vigilance from the orthopaedic block of our institution, which had to intervene to change a trident ceramic insert in a patient who had been wearing a hip replacement for 13 years.It is an implant of reference 625-0t-28d and lot number u5570402 or 433475g ceramic insert broken inside the liner of the cotyle.Presence of metalosis" update: 10 july 2019.As per medical review "cup malposition in excessive inclination of 66° has contributed to an overload condition in the arthroplasty bearing resulting in a ceramic liner fracture after 13 years requiring revision surgery.Also from medical review "the reported metallosis is secondary to contact of the ceramic femoral head with the metal of the cup shell after bearing fracture.".
 
Manufacturer Narrative
An event regarding crack/fracture and metallosis (fretting) involving a ceramic liner was reported.The event of crack/fracture was confirmed by medical review and material analysis of the returned device.Metallosis was confirmed based on the medical review.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 14 october 2019.This inspection indicated: the trident insert was returned fractured; approximately 10% of the ceramic insert was returned.The fracture surfaces were obscured by post-fracture chipping , no additional analysis was performed on the insert.Material evaluation was completed and indicated the following comments: the returned ceramic insert had fractured.Damage was observed on the insert fragments, sleeve and head consistent with articulating against each other after the insert fractured.A continuous metal transfer ring was not observed at the proximal end of the head taper.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: cup malposition in excessive inclination of 66°has contributed to an overload condition in the arthroplasty bearing resulting in a ceramic liner fracture after 13-years requiring revision surgery[.] the reported metallosis is secondary to contact of the ceramic femoral head with the metal of the cup shell after bearing fracture.It would also be possible that the fractured cerclage cable has released some metal although it does not appear that this has contributed to the current type of failure.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.Conclusion: visual inspection was performed as part of the material analysis report (mar), dated 14 october 2019.This inspection indicated: the trident insert was returned fractured; approximately 10% of the ceramic insert was returned.The fracture surfaces were obscured by post-fracture chipping , no additional analysis was performed on the insert.Material evaluation was completed and indicated the following comments: the returned ceramic insert had fractured.Damage was observed on the insert fragments, sleeve and head consistent with articulating against each other after the insert fractured.A continuous metal transfer ring was not observed at the proximal end of the head taper.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The medical review indicates cup malposition in excessive inclination of 66°has contributed to an overload condition in the arthroplasty bearing resulting in a ceramic liner fracture after 13-years requiring revision surgery.The reported metallosis is secondary to contact of the ceramic femoral head with the metal of the cup shell after bearing fracture.It would also be possible that the fractured cerclage cable has released some metal although it does not appear that this has contributed to the current type of failure.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIDENT ALUMINA INSERT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8629398
MDR Text Key145688618
Report Number0002249697-2019-02040
Device Sequence Number1
Product Code MRA
UDI-Device Identifier04546540516831
UDI-Public04546540516831
Combination Product (y/n)N
PMA/PMN Number
P000013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2008
Device Catalogue Number625-0T-28D
Device Lot NumberU5570402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient Weight72
-
-