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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#4R; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#4R; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number 6265-5214
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 11/23/2018
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.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 returned.
 
Event Description
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) 2009 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.
 
Manufacturer Narrative
Additional information: update to patient information and device information received.An event regarding disassociation, abnormal ion levels and wear involving a citation 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 records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary operative reports, clinical and past medical history, serial dated x-rays and examination of explanted components.-product 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.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.
 
Event Description
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) 2009 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.
 
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Brand Name
CITATION TMZF HA SHORT SIZE#4R
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8619769
MDR Text Key145395525
Report Number0002249697-2019-01978
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K053528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2013
Device Catalogue Number6265-5214
Device Lot Number27169302
Was Device Available for Evaluation? No
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age89 YR
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