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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 56X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
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DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 56X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS Back to Search Results
Model Number 1100-56-610
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 05/05/2021
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
Single stage revision of global unite anatomic shoulder replacement due to confirmed infection.Humeral head, proximal body and glenoid component removed, area flushed, new implants put in.Doi: (b)(6) 2020, dor: (b)(6) 2021, right 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
GLOBAL UNITE HEAD 56X18 ECC
Common Device Name
GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11945833
Report Number1818910-2021-11930
Device Sequence Number19891078
Product Code HSD
UDI-Device Identifier10603295004776
UDI-Public10603295004776
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K101996
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 05/05/2021
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 Number1100-56-610
Device Catalogue Number110056610
Device Lot NumberC73962
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/02/2021
Supplement Date Received by Manufacturer06/30/2021
Initial Report FDA Received Date06/07/2021
Supplement Report FDA Received Date07/02/2021
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
BIOSTOP G CEM RESTR 14MM; CROSSLINK ANCHOR PG GLENOID 56; GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE HEAD 56X18 ECC; GLOBAL UNITE STD STEM SZ 14; BIOSTOP G CEM RESTR 14MM; CROSSLINK ANCHOR PG GLENOID 56; GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE HEAD 56X18 ECC; GLOBAL UNITE STD STEM SZ 14
Outcome Attributed to Adverse Event Required Intervention;
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