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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 DXTEND RETENT PE CUP D38 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
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DEPUY FRANCE SAS 3003895575 DXTEND RETENT PE CUP D38 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP Back to Search Results
Catalog Number 130738106
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Joint Dislocation (2374); No Code Available (3191)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Arthroplasty has dislocated the reverse shoulder replacement and will be revised for instability.
 
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.
 
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Brand Name
DXTEND RETENT PE CUP D38 +6MM
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
Manufacturer (Section D)
DEPUY FRANCE SAS 3003895575
7 allée irène joliot curie
bp 256
saint priest cedex 69801
FR  69801
MDR Report Key8256555
Report Number1818910-2019-81219
Device Sequence Number13934041
Product Code HSD
UDI-Device Identifier10603295027355
UDI-Public10603295027355
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/20/2018
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
Operator of Device Health Professional
Device Catalogue Number130738106
Device Lot Number5305263
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/20/2018
Supplement Date Received by Manufacturer01/22/2019
Initial Report FDA Received Date01/17/2019
Supplement Report FDA Received Date02/04/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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