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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; TOTAL HIP PROSTHESIS
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ORTHO DEVELOPMENT PIVOT; TOTAL HIP PROSTHESIS Back to Search Results
Model Number 133-2247
Device Problem Migration (4003)
Patient Problem Arthralgia (2355)
Event Date 05/17/2019
Event Type  Injury  
Event Description
The patient experienced postoperative dislocation after bipolar hip arthroplasty.At the initial surgery on (b)(6) 2019, it was confirmed that the cup and head were firmly attached.Subsequent to the initial surgery, an x-ray determined that the head was dislocated from the cup and the cup was dislocated from the acetabulum.On (b)(6) 2019, the surgeon performed a revision to replace the cup and the femoral head.This report is one of two for this incident.
 
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Brand Name
PIVOT
Type of Device
TOTAL HIP PROSTHESIS
Manufacturer (Section D)
ORTHO DEVELOPMENT
12187 s. business park drive
draper, ut
Manufacturer (Section G)
ORTHO DEVELOPMENT
12187 s. business park drive
draper, ut
Manufacturer Contact
drew weaver
12187 s. business park drive
draper, ut 
5539991
MDR Report Key10153488
MDR Text Key195115090
Report Number1722511-2020-00005
Device Sequence Number1
Product Code KWY
UDI-Device Identifier0822409015160
UDI-Public(01)0822409015160(17)250710(10)A196578
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050966
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/20/2020
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 Number133-2247
Device Lot NumberA196578
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/20/2020
Initial Date FDA Received06/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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