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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6021-0435
Device Problems Break (1069); Entrapment of Device (1212); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 01/11/2017
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
Revision for trunnion wear and stem and head disassociation.Patient was scheduled for incision and drainage with possible head and poly exchange.After exposure trunnion was noticeably worn and femoral head was no longer engaged.The inserter (1020-1600) tip broke off inside the accolade stem.Poly and head exchange became total hip revision with extended trochanteric osteotomy due to stem inserter breaking.Case turned into hip revision because the implanted hip stem was not usable.Attempted to extract the stem.
 
Manufacturer Narrative
An event regarding disassociation involving an accolade stem was reported.The event was confirmed.-device evaluation and results: mar concluded: "damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock.A fractured inserter/extractor was observed in the stem.The fracture was consistent with an overload condition.Eds showed the inserter/extractor was consistent with astm f1537 alloy.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as medical records were not returned.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the investigation concluded that there was a loss of taper lock between the head and the stem.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
 
Event Description
Revision for trunnion wear and stem and head disassociation.Patient was scheduled for incision and drainage with possible head and poly exchange.After exposure trunnion was noticeably worn and femoral head was no longer engaged.The inserter (1020-1600) tip broke off inside the accolade stem.Poly and head exchange became total hip revision with extended trochanteric osteotomy due to stem inserter breaking.Case turned into hip revision because the implanted hip stem was not usable.Attempted to extract the stem.
 
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Brand Name
ACCOLADE PLUS TMZF HIP STEM #4
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
suzanne neuschwanter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6307198
MDR Text Key66711489
Report Number0002249697-2017-00477
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2014
Device Catalogue Number6021-0435
Device Lot Number29731302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received03/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2009
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;
Patient Age66 YR
Patient Weight102
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