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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

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DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT Back to Search Results
Model Number 1363-10-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 08/14/2020
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
It was reported that the patient was experiencing hip pain.The unipolar size 49 and +0 spacer were removed and total hip was done to relieve this issue.Doi: (b)(6) 2016.Dor: (b)(6) 2020.Affected side: left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
TAPERED SPACER ARTICUL/EZE +0
Type of Device
HEMI HIP IMPLANT : HIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10471515
MDR Text Key204924812
Report Number1818910-2020-19058
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032670
UDI-Public10603295032670
Combination Product (y/n)N
PMA/PMN Number
K903084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/14/2020
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 Model Number1363-10-000
Device Catalogue Number136310000
Device Lot Number740449
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/14/2020
Initial Date FDA Received08/31/2020
Supplement Dates Manufacturer Received09/28/2020
Supplement Dates FDA Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODULAR CATHCART BALL 49MM OD; MODULAR CATHCART BALL 49MM OD
Patient Outcome(s) Required Intervention;
Patient Age80 YR
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