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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE ECC HD 52X18; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
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DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE ECC HD 52X18; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS Back to Search Results
Model Number 1128-52-110
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fall (1848); No Code Available (3191)
Date of Event 07/14/2020
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
It was reported that the patient stated that a year after his surgery, he fell.A torn subscap was discovered as the reason for a loose component.Glenoid was worn due to this soft tissue lax and was removed.Head was also replaced with a larger head to help tighten the space.Doi: (b)(6) 2016, dor: (b)(6) 2020, right shoulder.
 
Additional 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 ADVANTAGE ECC HD 52X18
Common Device Name
GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10320088
Report Number1818910-2020-16800
Device Sequence Number3178166
Product Code HSD
UDI-Device Identifier10603295005223
UDI-Public10603295005223
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
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) 07/14/2020
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? No
Operator of Device Health Professional
Device Model Number1128-52-110
Device Catalogue Number112852110
Device Lot NumberD16032311
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/14/2020
Supplement Date Received by Manufacturer08/28/2020
Initial Report FDA Received Date07/24/2020
Supplement Report FDA Received Date08/31/2020
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
CROSSLINK ANCHOR PG GLENOID 52; GLOBAL ADVANTAGE ECC HD 52X18; CROSSLINK ANCHOR PG GLENOID 52; GLOBAL ADVANTAGE ECC HD 52X18
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
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