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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 53MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

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DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 53MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI Back to Search Results
Model Number 1363-53-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 07/20/2020
Event Type  Injury  
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
The patient was revised due to unipolar hip groin pain.Doi: (b)(6) 2019; dor: (b)(6) 2020; affected side: right 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
MODULAR CATHCART BALL 53MM OD
Type of Device
HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10344541
MDR Text Key201049750
Report Number1818910-2020-17200
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032854
UDI-Public10603295032854
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 07/20/2020
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 Number1363-53-000
Device Catalogue Number136353000
Device Lot NumberHW8956
Initial Date Manufacturer Received 07/20/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received09/03/2020
Supplement Dates FDA Received09/04/2020
Patient Sequence Number1
Treatment
TAPERED SPACER ARTICUL/EZE +0; TAPERED SPACER ARTICUL/EZE +0
Patient Outcome(s) Required Intervention;
Patient Age86 YR
Patient Weight100
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