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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TAPERED SPACER ARTICUL/EZE +5; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS, INC. 1818910 TAPERED SPACER ARTICUL/EZE +5; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT Back to Search Results
Catalog Number 136312000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/04/2019
Event Type  Injury  
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
The patient was revised to convert a hemi-hip to a total hip due to pain.
 
Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
TAPERED SPACER ARTICUL/EZE +5
Type of Device
HEMI HIP IMPLANT : HIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8274045
MDR Text Key133976091
Report Number1818910-2019-82144
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032687
UDI-Public10603295032687
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number136312000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/04/2019
Initial Date FDA Received01/24/2019
Supplement Dates Manufacturer Received02/06/2019
Supplement Dates FDA Received02/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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