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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 ECC GLENOSPHERE TRIAL D42MM; EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS
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DEPUY FRANCE SAS - 3003895575 ECC GLENOSPHERE TRIAL D42MM; EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS Back to Search Results
Catalog Number 230760042
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 10/29/2018
Type of Reportable Event Malfunction
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
Broken.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.Depuy considers the investigation closed.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 Name
ECC GLENOSPHERE TRIAL D42MM
Common Device Name
EXTREMITY INSTRUMENTS : GLENOSPHERE TRIALS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key8090383
Report Number1818910-2018-76068
Device Sequence Number1437137
Product Code LXH
UDI-Device Identifier10603295115977
UDI-Public10603295115977
Combination Product (Y/N)N
Initial Reporter CountrySW
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number230760042
Device Lot Number5244678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Initial Date Received by Manufacturer 10/29/2018
Supplement Date Received by Manufacturer11/26/2018
Initial Report FDA Received Date11/20/2018
Supplement Report FDA Received Date12/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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