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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND MODULAR HUM STEM D12 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY IRELAND - 9616671 DXTEND MODULAR HUM STEM D12 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Model Number 130712000
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 04/13/2021
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
Removal of old components for infection and another company cement spacer went in.Doi: (b)(6) 2021 dor: (b)(6) 2021 unk shoulder.
 
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
DXTEND MODULAR HUM STEM D12 HA
Common Device Name
DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg, ringaskiddy co
cork
EI 
MDR Report Key11711426
Report Number1818910-2021-08475
Device Sequence Number19660537
Product Code KWS
UDI-Device Identifier10603295027171
UDI-Public10603295027171
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K021478
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/13/2021
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 Number130712000
Device Catalogue Number130712000
Device Lot Number5369547
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/13/2021
Supplement Date Received by Manufacturer07/06/2021
Initial Report FDA Received Date04/22/2021
Supplement Report FDA Received Date07/07/2021
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 GLENOSPHERE ECC D38MM; DXTEND HIGHMO PE CUP D38 +6MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X30MM
Outcome Attributed to Adverse Event Required Intervention;
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