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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*EXTENSION REAMER HUDSON; HIP INSTRUMENTS : ADAPTORS

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DEPUY ORTHOPAEDICS INC US S-ROM*EXTENSION REAMER HUDSON; HIP INSTRUMENTS : ADAPTORS Back to Search Results
Model Number 53-0300
Device Problem Unintended Movement (3026)
Patient Problem Insufficient Information (4580)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument partially confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The primary surgery was performed on an unknown date via tha.It was reported that the revision surgery was performed on (b)(6) 2020.The reason of the revision surgery is the cup sinking to the acetabular.The fixation of the stem was good, but it was removed because it interrupted to remove the cup.During the surgery, when the surgeon set a cone reamer to the extension reamer hudson, attached them to a power tool and checked the action, the rotation was eccentric.The surgeon used the devices to drill the femoral medullary cavity, the surgeon had a risk to break the femur due to the device¿s eccentric rotation.He proceeded with the procedure carefully and as a result the duration of the surgery was extended about less than 30 minutes.The feared event did not happen.No further information is available.
 
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Type of Device
HIP INSTRUMENTS : ADAPTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11026941
MDR Text Key229608564
Report Number1818910-2020-27132
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295171522
UDI-Public10603295171522
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number53-0300
Device Catalogue Number530300
Device Lot NumberAB0203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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