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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 6020-0335
Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Ambulation Difficulties (2544); Metal Related Pathology (4530)
Event Date 08/11/2020
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.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.Device not returned.
 
Event Description
Patient came to cleveland clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunnion wear of the femoral stem.During surgery was noted the trunnion had worn to the point that the femoral head had came off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.
 
Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem which was mated with a lfit v40 cocr head was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: the reported device was not returned however a photograph of the explanted stem was provided for review.There are scratch marks and tissue on the explanted stem.The stem trunnion was penciled.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.The event likely represents failure of a recalled lfit device.Obtaining the catalog number and/or the implants may allow confirmation.-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: a review of the provided medical records by a clinical consultant revealed that the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Patient came to cleveland clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunion wear of the femoral stem.During surgery was noted the trunion had worn to the point that the femoral head had came off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.
 
Event Description
Patient came to cleveland clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunion wear of the femoral stem.During surgery was noted the trunion had worn to the point that the femoral head had came off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.*update on 04-aug-2021 per medical review: ¿post-operatively it was stated that there was catastrophic failure of the hip, trunnion failure at the taper, metal disease, femoral osteolysis with a well fixed stem, wear through and destruction of the acetabulum, periacetabular osteolysis and abductor destruction.¿.
 
Manufacturer Narrative
Reported event: an event regarding disassociation wear/ metallosis, and osteolysis involving an accolade stem which was mated with a lfit v40 cocr head was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: the reported device was not returned however a photograph of the explanted stem was provided for review.There are scratch marks and tissue on the explanted stem.The stem trunnion was worn to a pencil tip.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: a review of the provided medical records by a clinical consultant stated the following: adverse event identified: revision of left hip arthroplasty due to disassociation of a femoral head from a tmzf stem and trunnionosis.Hazards: failure of trunnion-head construct.Conclusion of assessment: review of the records provided confirmed the implant disassociation and trunnion wear.Review of implant stickers could define if the head was an lfit or associated with an lfit problem.Obtaining the implant may provide additional insight into the mechanism of disassociation.-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: a review of the provided medical records by a clinical consultant revealed that the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
ACCOLADE TMZF HIP STEM #3
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 Key10497314
MDR Text Key205883221
Report Number0002249697-2020-01798
Device Sequence Number1
Product Code LPH
UDI-Device Identifier04546540510556
UDI-Public04546540510556
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 08/30/2021
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 Date05/31/2011
Device Model Number6020-0335
Device Catalogue Number6020-0335
Device Lot Number18758701
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/11/2020
Initial Date FDA Received09/04/2020
Supplement Dates Manufacturer Received10/20/2020
08/04/2021
Supplement Dates FDA Received11/13/2020
08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
Patient Weight94
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