Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 DXTEND MOD EPI 1 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY IRELAND 9616671 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 Osseointegration Problem (3003)
Health Effect - Clinical Codes Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event 04/16/2021
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 humeral fracture and loosening of the stem at the bone to implant interface.The stem/body was replaced with new components.There were no deficiencies noted with the implants.The implants are unavailable for return.Doi: unknown, dor: (b)(6) 2021, unknown affected side.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DXTEND MOD EPI 1 ECC RIGHT HA
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg
cork 69801
EI  69801
MDR Report Key11737618
Report Number1818910-2021-09029
Device Sequence Number11720615
Product Code HSD
UDI-Device Identifier10603295027300
UDI-Public10603295027300
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
PMA/510(K) Number
K192855
Number of Events Summarized1
Summary Report (Y/N)N
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) 04/16/2021
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? Yes
Operator of Device Health Professional
Device Model Number130720103
Device Catalogue Number130720103
Device Lot Number9590233
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/16/2021
Supplement Date Received by Manufacturer06/10/2021
Initial Report FDA Received Date04/28/2021
Supplement Report FDA Received Date06/11/2021
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
DXTEND MODULAR HUM STEM D14 HA; DXTEND STAND PE CUP D38 +6MM; DXTEND MODULAR HUM STEM D14 HA; DXTEND STAND PE CUP D38 +6MM
Outcome Attributed to Adverse Event Required Intervention;
-
-