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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS 1818910 SELF CENT HIP 46X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS 1818910 SELF CENT HIP 46X28 BRN HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Model Number 1035-46-000
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
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
Surgeon is complaining the fit between the inlay and the metal shell in the self centering bipolar head. A larger clearance of the components than in the past was observed and clarification was requested. Surgery was finished anyhow, an adverse patient consequence was not reported, a surgical delay was not reported.
 
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Brand NameSELF CENT HIP 46X28 BRN
Type of DeviceHEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
randall
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11257799
MDR Text Key229580708
Report Number1818910-2021-02165
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K812672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1035-46-000
Device Catalogue Number103546000
Device Lot NumberJ73U96
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 Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2020
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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