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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 128 SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

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DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 128 SZ 12; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY Back to Search Results
Model Number 1100-40-010
Device Problem Difficult to Remove (1528)
Patient Problem Insufficient Information (4580)
Event Date 06/09/2021
Event Type  malfunction  
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 Description
It was reported that the patient had a revision surgery plan to convert a global unite proximal body to an epiphysis for a reverse shoulder arthroplasty.Surgeon was unable to "unscrew" the proximal body from the stem.The stem/body construct was implanted in the patient.The surgeon ended up removing the entire stem/body construct.Two hex screwdrivers were broken trying to remove screw.A surgical delay of 30 minutes was also reported.Doi: unknown; dor: (b)(6) 2021; right shoulder.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand Name
GLBL UNITE ANT BODY 128 SZ 12
Type of Device
GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12065517
MDR Text Key258388547
Report Number1818910-2021-13564
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295004424
UDI-Public10603295004424
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1100-40-010
Device Catalogue Number110040010
Device Lot Number8292578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Initial Date Manufacturer Received 06/09/2021
Initial Date FDA Received06/25/2021
Supplement Dates Manufacturer Received06/23/2021
08/02/2021
Supplement Dates FDA Received07/07/2021
08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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