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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 6721-0535
Device Problems Unintended Movement (3026); Migration (4003)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/11/2020
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
It was reported that the patient's left hip was revised due to stem subsidence and suspected (not confirmed) femoral fracture.The stem, head and liner were revised to a restoration modular stem construct, new head, adm/ mdm insert, and mdm metal liner.Rep confirmed that there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.Reported event an event regarding subsidence and periprosthetic fracture 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: no medical records were received for review with a clinical consultant.-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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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.H3 other text : device not returned.
 
Event Description
It was reported that the patient's left hip was revised due to stem subsidence and suspected (not confirmed) femoral fracture.The stem, head and liner were revised to a restoration modular stem construct, new head, adm/ mdm insert, and mdm metal liner.Rep confirmed that there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
 
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Brand Name
SIZE 5 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
MDR Report Key10643722
MDR Text Key210378246
Report Number0002249697-2020-02067
Device Sequence Number1
Product Code LPH
UDI-Device Identifier04546540669506
UDI-Public04546540669506
Combination Product (y/n)N
PMA/PMN Number
K143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/19/2020
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 Model Number6721-0535
Device Catalogue Number6721-0535
Device Lot Number78334606
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received10/07/2020
Supplement Dates Manufacturer Received11/18/2020
Supplement Dates FDA Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age78 YR
Patient Weight64
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