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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6020-0435
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)
Event Date 02/28/2017
Event Type  Injury  
Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not available.
 
Event Description
It was reported that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2010 and was revised on (b)(6) 2017.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, and excessive levels of cobalt and chromium in his blood.
 
Manufacturer Narrative
Additional information: update to device details and executive summary.An event regarding disassociation and fretting involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary operative report, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: indicated 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 lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as primary operative report, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2010 and was revised on (b)(6) 2017.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, and excessive levels of cobalt and chromium in his blood.As per opt report: "we noted the broken head with the trunnion that was significantly damaged.There was a significant amount of metal debris and black, grainy tissue with obvious metal staining and disruption.".
 
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Brand Name
ACCOLADE 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
MDR Report Key8155831
MDR Text Key130074973
Report Number0002249697-2018-04005
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 consumer,other
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/30/2014
Device Catalogue Number6020-0435
Device Lot Number30140303
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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