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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY FRANCE SAS - 3003895575 DXTEND MODULAR HUM STEM D10 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Model Number 130710000
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 11/03/2020
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 loose stem at bone to implant interface.Doi: (b)(6) 2020.Dor: (b)(6) 2020; 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 review: 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 lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
DXTEND MODULAR HUM STEM D10 HA
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key10861852
Report Number1818910-2020-24932
Device Sequence Number3710967
Product Code KWS
UDI-Device Identifier10603295027126
UDI-Public10603295027126
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K021478
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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,Followup
Report Date (Section B) 11/03/2020
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? Yes
Operator of Device Health Professional
Device Model Number130710000
Device Catalogue Number130710000
Device Lot Number5354291
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/03/2020
Supplement Date Received by Manufacturer11/03/2020
12/16/2020
Initial Report FDA Received Date11/18/2020
Supplement Report FDA Received Date11/24/2020
12/17/2020
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 MOD EPI 1 ECC LEFT HA.; DXTEND STAND PE CUP D38 +3MM.; DXTEND STAND PE CUP D38 +3MM.; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND.; DXTEND STAND PE CUP D38 +3MM; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
Outcome Attributed to Adverse Event Required Intervention;
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