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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE ECC D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
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DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE ECC D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE Back to Search Results
Model Number 130760042
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/02/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The patient was revised to address infection.Doi: (b)(6) 2017; dor: (b)(6) 2021; left shoulder.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot - the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
DXTEND GLENOSPHERE ECC D42MM
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key11497615
Report Number1818910-2021-05239
Device Sequence Number2980236
Product Code HSD
UDI-Device Identifier10603295027751
UDI-Public10603295027751
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K120174
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/02/2021
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 Model Number130760042
Device Catalogue Number130760042
Device Lot Number5277656
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/02/2021
Supplement Date Received by Manufacturer04/16/2021
Initial Report FDA Received Date03/16/2021
Supplement Report FDA Received Date04/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
BONE CEMENT (UNK MFR & PROD INFO).; DXTEND GLENOSPHERE ECC D42MM.; DXTEND METAGLENE.; DXTEND MOD CENT EPI 2 HA.; DXTEND MODULAR HUM STEM D14 HA.; DXTEND SCREW LOCK D4.5X30MM.; DXTEND SCREW LOCK D4.5X30MM.; X-LINK HIMO HUM CUP 42+6.
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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