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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6720-0837
Device Problems Material Fragmentation (1261); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Date 10/09/2018
Event Type  Injury  
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.Device not returned.
 
Event Description
It was reported through a medwatch report (mw5087699) "required hip replacement.Doctor installed a stryker accolade femoral component.Required three more surgeries including two hip replacements.Five plus years of pain." spoke to patient: patient stated not sure if they were revised to stryker devices.
 
Manufacturer Narrative
Correction: update to implant date.Added device catalog and lot numbers.An event regarding fretting involving a accolade stem was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: there is no examination of explanted components and no surgical pathology report confirming a diagnosis of metalosis/trunnionosis or altr.The description of pain in the right hip ¿since surgery¿ would preclude trunnionosis or metalosis as the cause at the immediate post-operative period.Moderately elevated plasma ion levels may relate to the longstanding left total hip arthroplasty and should not be a primary indication for revision surgery.No operative report for the stated 2016 surgery for greater trochanteric debridement and heterotopic ossification excision is available, and the recurrence of these symptoms are noted.There is no evidence that either the october 9, 2018 revision surgery or the october 30, 2018 hematoma i&d surgery were related to factors of implant design, manufacturing or materials.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: medical review could not confirm the reported diagnosis of metalosis/trunnionosis.Return of the device and pathology reports are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported through a medwatch report (mw5087699) "required hip replacement.Doctor installed a stryker accolade femoral component.Required three more surgeries including two hip replacements.Five plus years of pain." spoke to patient: patient stated not sure if they were revised to stryker devices.Update 13-dec-2019: as per opt report received, the patient was implanted on (b)(6) 2014 and revised on (b)(6) 2018 due to metallosis/trunnionosis.The femoral head remained implanted.
 
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Brand Name
SIZE 8 ACCOLADE II 132 DEG
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 Key8870449
MDR Text Key153566722
Report Number0002249697-2019-02766
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date10/31/2017
Device Catalogue Number6720-0837
Device Lot Number41765006
Was Device Available for Evaluation? No
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
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