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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 43X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS INC US SELF CENT HIP 43X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-43-000
Device Problem Device Damaged Prior to Use (2284)
Patient Problem Insufficient Information (4580)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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
It was reported that the bipolar head was defective when opened sterile onto filed. The locking mechanism between the poly and the shell did not seat. Poly would slide and move within metal head. Dr. Did not feel comfortable using. Original implant date unknown. No surgical delay. Doi: unknown, doe: (b)(6) 2021, affected side: unknown.
 
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Brand NameSELF CENT HIP 43X28 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 Key12532358
MDR Text Key273319772
Report Number1818910-2021-21147
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1035-43-000
Device Catalogue Number103543000
Device Lot NumberJ44H01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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