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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 STAND CUP TRIAL D38 +9MM EXTREMITY INSTRUMENTS : HUMERAL TRIALS

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DEPUY FRANCE SAS 3003895575 STAND CUP TRIAL D38 +9MM EXTREMITY INSTRUMENTS : HUMERAL TRIALS Back to Search Results
Catalog Number 230738409
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2019
Event Type  malfunction  
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 humeral cup trials have shaving of plastic coming off of them. Had to open three different trays for case. All went well and nothing left in patient.
 
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.
 
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Brand NameSTAND CUP TRIAL D38 +9MM
Type of DeviceEXTREMITY INSTRUMENTS : HUMERAL TRIALS
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex 69801
FR 69801
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
b.p. 256
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8269019
MDR Text Key133842404
Report Number1818910-2019-81855
Device Sequence Number1
Product Code LHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number230738409
Device Lot Number5281014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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