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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSENSUS ORTHOPEDICS, INC. BIPOLAR ASSEMBLY
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CONSENSUS ORTHOPEDICS, INC. BIPOLAR ASSEMBLY Back to Search Results
Catalog Number 1015-0-4850
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/24/2019
Event Type  Injury  
Manufacturer Narrative
Dhr review was performed. No product evaluation has yet been performed. Explant was not returned at the time of this initial report. No x-rays were provided by hospital for evaluation.
 
Event Description
On (b)(6) 2019 this patient presented at the (b)(6) emergency dept. After sustaining a "hard fall". Clinical evaluation and x-ray findings yielded a diagnosis of a bipolar hip replacement which was reached and the decision was made by the emergency room physician to attempt a reduction of the dislocation. At some point during the attempted reduction, disassociation of the 28mm femoral head from the bi-polar insert occurred. The patient was then admitted to (b)(6) m. D. For further evaluation and treatment at (b)(6).
 
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Brand NameBIPOLAR ASSEMBLY
Type of DeviceBIPOLAR ASSEMBLY
Manufacturer (Section D)
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way
el dorado hills CA 95762
Manufacturer (Section G)
CONSENSUS ORTHOPEDICS, INC.
1115 windfield way
el dorado hills CA 95762
Manufacturer Contact
dan lubeck
1115 windfield way
el dorado hills, CA 95762
9153557158
MDR Report Key8927045
MDR Text Key155503638
Report Number2952369-2019-00005
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1015-0-4850
Device Lot Number485712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/23/2019 Patient Sequence Number: 1
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