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 SIZE 6 ACCOLADE II 127 DEG; 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 SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6721-0635
Device Problems Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)
Patient Problem Joint Dislocation (2374)
Event Date 07/14/2023
Event Type  Injury  
Event Description
It was reported that the patient's left hip was revised.Patient presented to the er with a dislocation.A closed reduction was attempted and was unsuccessful.During the revision, the poly insert was found to have dissociated from the femoral head and dislocated from the metal liner.The poly insert, femoral head and stem were revised (stem was revised to add version to the hip construct).The metal liner and shell were retained.
 
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.H3 other text : device not returned to the manufacturer.
 
Manufacturer Narrative
An event regarding dislocation involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicates some minor damage consistent with implantation/explantation attempt.Nothing else was observed.Clinician review: no medical records were received for review with a clinical consultant.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: it was reported that the patient was revised due to disassociation of the ceramic head from the adm poly liner and dislocation of the adm poly liner from the mdm metal liner.Visual inspection of the returned devices indicated that the head and liner were damaged from the disassociation/dislocation event as well as explantation.The stem appeared unremarkable.The metal mdm liner was not revised.Further information such as pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.It was reported that the stem was also revised to add version to the hip construct; it is likely that the choice of stem implant contributed to the construct failure 3 days post-operative.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 patient's left hip was revised.Patient presented to the er with a dislocation.A closed reduction was attempted and was unsuccessful.During the revision, the poly insert was found to have dissociated from the femoral head and dislocated from the metal liner.The poly insert, femoral head and stem were revised (stem was revised to add version to the hip construct).The metal liner and shell were retained.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIZE 6 ACCOLADE II 127 DEG
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
EI   NA
Manufacturer Contact
arokiya raj
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key17438996
MDR Text Key320207082
Report Number0002249697-2023-00872
Device Sequence Number1
Product Code LPH
UDI-Device Identifier04546540669513
UDI-Public04546540669513
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number6721-0635
Device Lot Number10573052
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2023
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) Hospitalization; Required Intervention;
-
-