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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 8; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Model Number 1100-08-100
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 06/05/2020
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 pain.All components were removed and converted to a non-depuy reverse total shoulder.No additional information is available.Doi: (b)(6) 2018.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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.
 
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Brand Name
GLOBAL UNITE STD STEM SZ 8
Common Device Name
GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10167268
Report Number1818910-2020-14057
Device Sequence Number3637118
Product Code HSD
UDI-Device Identifier10603295004042
UDI-Public10603295004042
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K101996
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 06/05/2020
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 Number1100-08-100
Device Catalogue Number110008100
Device Lot Number8564668
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/05/2020
Supplement Date Received by Manufacturer07/21/2020
Initial Report FDA Received Date06/18/2020
Supplement Report FDA Received Date07/22/2020
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
GLOBAL UNITE BODY SZ 10 -5.; GLOBAL UNITE COLLAR SZ 44.; GLOBAL UNITE HEAD 44X12.; GLOBAL UNITE BODY SZ 10 -5; GLOBAL UNITE COLLAR SZ 44; GLOBAL UNITE HEAD 44X12
Outcome Attributed to Adverse Event Required Intervention;
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