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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Corroded (1131); Degraded (1153)
Patient Problems Foreign Body Reaction (1868); No Code Available (3191)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).
 
Event Description
The primary surgery was performed on (b)(6) 2008 via tha. After the surgery, the cup¿s setting angle became steep over time. There was fear of armd occurring due to mom liner, so the surgeon performed the revision surgery on (b)(6) 2020. During the revision surgery, the pseudotumor was not found, but the black-ring was found at the head neck junction, the surgeon judged trunnionosis. After removing the liner and the screw, the surgeon checked the fixation of the cup, the cup was loosened and removed easily. The surgeon implanted a pinnacle gription cup with screws and a poly liner. Due to trunninosis, the surgeon considered to remove the stem, however, there was fear of remaining breakage fragment of the stem because the surgeon found a possibility of the breakage of distal stem¿s slot by x-ray photos. The surgeon relinquished to remove the stem. The surgeon replaced the head, the stem was remained. The surgery was completed without any surgical delay. No further information is available.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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 Key10562592
MDR Text Key208153642
Report Number1818910-2020-20575
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/21/2020 Patient Sequence Number: 1
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