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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 44X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 44X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-44-000
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
During the surgery for subcapital fracture of the femur performed at the hospital of (b)(6) on (b)(6) 2021, during the implantation of the bipolar. It was noticed a failure to fix the polyethylene dome insert inside the metal dome itself (never noticed before). In fact, it is detailed that with the simple marginal pressure of the fingers on the pe, the displacement of the insert was shown, this situation also occurred with the presence of the inserted head and did not give a guarantee of stability, indeed highlighting potential problems of disassembly and greater wear. It was decided to remove the piece and open the dome of a different diameter (1 mm larger) but the tests carried out on the operating table the situation was similar and unsatisfactory to give guarantees to the definitive implant. The intervention was completed with the hybrid implant using the dome of another company available in our operating room.
 
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Brand NameSELF CENT HIP 44X28 GRY
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
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 Key11689330
MDR Text Key246246346
Report Number1818910-2021-08215
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K812672
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,Followup,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1035-44-000
Device Catalogue Number103544000
Device Lot NumberJ15H08
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 Received06/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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