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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +3 S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 36MM +3 S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Model Number 1365-36-220
Device Problem Noise, Audible (3273)
Patient Problem No Code Available (3191)
Event Date 05/02/2013
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. (b)(4).

 
Event Description

The patient was revised because of squeaking. Update ad 30 apr 2018: the receipt of ppf and sticker sheets.

 
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Brand NameDELTA CER HEAD 11/13 36MM +3
Type of DeviceS-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg ringaskiddy
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key8021253
MDR Text Key125586153
Report Number1818910-2018-73930
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2017
Device MODEL Number1365-36-220
Device Catalogue Number136536220
Device LOT Number3466690
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/03/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/30/2018 Patient Sequence Number: 1
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