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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD CENT EPI 2 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
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DEPUY FRANCE SAS - 3003895575 DXTEND MOD CENT EPI 2 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY Back to Search Results
Model Number 130720201
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 MOD CENT EPI 2 HA
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key11497618
Report Number1818910-2021-05242
Device Sequence Number16889033
Product Code HSD
UDI-Device Identifier10603295027317
UDI-Public10603295027317
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
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 Number130720201
Device Catalogue Number130720201
Device Lot Number5269074
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
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		1818910-08/31/2017-002-R
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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