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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Date 06/10/2020
Event Type  Injury  
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
The patient was revised due to peri prosthetic fracture.Doi: (b)(6) 2016, dor: (b)(6) 2020, right shoulder.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
GLOBAL UNITE STD STEM SZ 8
Type of Device
GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10192083
MDR Text Key196414093
Report Number1818910-2020-14401
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295004042
UDI-Public10603295004042
Combination Product (y/n)N
PMA/PMN Number
K101996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1100-08-100
Device Catalogue Number110008100
Device Lot Number8096179
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DXTEND GLENOSPHERE STD D38MM; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND STAND PE CUP D38 +3MM; GLOBAL UNITE STD STEM SZ 8
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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