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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD EPI 1 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
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DEPUY FRANCE SAS - 3003895575 DXTEND MOD EPI 1 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY Back to Search Results
Model Number 130720103
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bone Fracture(s) (1870); No Code Available (3191)
Date of Event 06/10/2020
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 due to peri prosthetic fracture.Doi: (b)(6) 2016, 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 at this time.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 MOD EPI 1 ECC RIGHT 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 Key10192085
Report Number1818910-2020-14402
Device Sequence Number886582
Product Code KWS
UDI-Device Identifier10603295027300
UDI-Public10603295027300
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K021478
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
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) 06/10/2020
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 Number130720103
Device Catalogue Number130720103
Device Lot Number5248006
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/10/2020
Supplement Date Received by Manufacturer07/24/2020
Initial Report FDA Received Date06/24/2020
Supplement Report FDA Received Date07/27/2020
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 STD D38MM; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND STAND PE CUP D38 +3MM; GLOBAL UNITE STD STEM SZ 8; DXTEND GLENOSPHERE STD D38MM; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND STAND PE CUP D38 +3MM; GLOBAL UNITE STD STEM SZ 8
Outcome Attributed to Adverse Event Required Intervention;
Patient Age70 YR
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