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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
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DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP Back to Search Results
Model Number 130738203
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2020
Event Type  malfunction  
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
It was reported that the poly was never seated all the way and that soft tissue was in the way.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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 may be re-opened as necessary.
 
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Brand Name
DXTEND STAND PE CUP D38 +3MM
Type of Device
DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key10364794
MDR Text Key201707506
Report Number1818910-2020-17560
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295027362
UDI-Public10603295027362
Combination Product (y/n)N
PMA/PMN Number
K062250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number130738203
Device Catalogue Number130738203
Was Device Available for Evaluation? No
Date Manufacturer Received09/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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