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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6021-2530
Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)
Patient Problems Ossification (1428); Injury (2348); Ambulation Difficulties (2544)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.
 
Event Description
It was reported that: "revision right total hip.The 40mm v40 taper cocr femoral head fell off the accolade tmzf stem.Original surgery was 2012.No additional information for this case.The primary surgery was done at another hospital.".
 
Event Description
It was reported that: "revision right total hip.The 40mm v40 taper cocr femoral head fell off the accolade tmzf stem.Original surgery was 2012.No additional information for this case.The primary surgery was done at another hospital.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation & corrosion involving unknown accolade tmzf stem was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on the the explanted stem and black tissues observed on the surface of the stem.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: heterotopic ossifications in and around the joint space in concert with a moderate overweight condition and larger head size have contributed to an overload condition in the arthroplasty to cause corrosion with ultimately loss of taper lock functionality and disassociation of the femoral head from the trunnion requiring revision surgery device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that patient's revision of right total hip due to disassociation and corrosion.The event was confirmed based on medical review.A review of the provided medical records and x-rays by a clinical consultant indicated: heterotopic ossifications in and around the joint space in concert with a moderate overweight condition and larger head size have contributed to an overload condition in the arthroplasty to cause corrosion with ultimately loss of taper lock functionality and disassociation of the femoral head from the trunnion requiring revision surgery.The reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on th explanted stem and black tissues observed on the surface of the stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
It was reported that: "revision right total hip.The 40mm v40 taper cocr femoral head fell off the accolade tmzf stem.Original surgery was 2012.No additional information for this case.The primary surgery was done at another hospital." update: "it was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6), 2007 and was revised on (b)(6) 2020.It is further alleged that intraoperative findings consisted of dissociation of the cobalt chrome head from the worn stem trunnion with bird beak pattern.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation & corrosion involving accolade tmzf stem was reported.The event was confirmed based on medical review.Method & results: -device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on the the explanted stem and black tissues observed on the surface of the stem.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: "principal cause of failure is contributed by the cup malposition of the right hip in low inclination and probably also low anteversion.This is a procedure-related factor because the surgeon is responsible for optimal component position.The choice for a 40-mm femoral head, also a procedure-related factor because of surgical decision making, might be mentioned as a relevant secondary factor because increase in head size is associated with an increase in angular speed in the bearing thereby increasing bearing friction.This may magnify the adverse effects of any present overload conditions although with perfect positioned components this would certainly not have represented a relevant failure introduction factor just by itself.From the patient-related perspective no major factors are evident.There was only a mild overweight condition with a bmi of 28 (25 max normal) and this should not be considered a relevant contributing factor.Also from the device-related perspective, there is no evidence to suggest that device-related factors might have contributed to the problem." -device history review: all 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 reported lot.Conclusion: it was reported that patient's revision of right total hip due to disassociation and corrosion.The event was confirmed based on medical review.Principal cause of failure is contributed by the cup malposition of the right hip in low inclination and probably also low anteversion.This is a procedure-related factor because the surgeon is responsible for optimal component position.The choice for a 40-mm femoral head, also a procedure-related factor because of surgical decision making, might be mentioned as a relevant secondary factor because increase in head size is associated with an increase in angular speed in the bearing thereby increasing bearing friction.This may magnify the adverse effects of any present overload conditions although with perfect positioned components this would certainly not have represented a relevant failure introduction factor just by itself.From the patient-related perspective no major factors are evident.There was only a mild overweight condition with a bmi of 28 (25 max normal) and this should not be considered a relevant contributing factor.Also from the device-related perspective, there is no evidence to suggest that device-related factors might have contributed to the problem." the reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on the the explanted stem and black tissues observed on the surface of the stem.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.If further information becomes available or the product is returned, this investigation will be re-opened.
 
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Brand Name
ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5
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 Key10413207
MDR Text Key203107970
Report Number0002249697-2020-01670
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2012
Device Catalogue Number6021-2530
Device Lot Number24548101
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/17/2020
Supplement Dates Manufacturer Received09/23/2020
08/16/2021
Supplement Dates FDA Received10/20/2020
09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight79
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