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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MBLOC HUM EPI 2 D12 LG; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
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DEPUY FRANCE SAS - 3003895575 DXTEND MBLOC HUM EPI 2 D12 LG; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY Back to Search Results
Model Number 130712210
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/25/2020
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 instability.Doi: (b)(6) 2018, dor: (b)(6) 2020, right 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.
 
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Brand Name
DXTEND MBLOC HUM EPI 2 D12 LG
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 Key10236745
Report Number1818910-2020-15072
Device Sequence Number594180
Product Code HSD
UDI-Device Identifier10603295027218
UDI-Public10603295027218
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K062250
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/25/2020
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 Number130712210
Device Catalogue Number130712210
Device Lot Number5296070
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/25/2020
Supplement Date Received by Manufacturer08/13/2020
Initial Report FDA Received Date07/06/2020
Supplement Report FDA Received Date08/14/2020
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
DXTEND GLENOSPHERE ECC D42MM; DXTEND HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND MBLOC HUM EPI 2 D12 LG; DXTEND RETENT PE CUP D42 +6MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X30MM; DXTEND SCREW NO LOCK D4.5X42MM; METAGLENE LONG PEG +10MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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