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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ANCHOR PEG GLENOID 48MM; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
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DEPUY ORTHOPAEDICS INC US GLOBAL ANCHOR PEG GLENOID 48MM; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID Back to Search Results
Model Number 1136-42-025
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 wear and loosening of the glenoid component at the bone to cement interface.Unknown cement was used.Doi: (b)(6) 2007, 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.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.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 ANCHOR PEG GLENOID 48MM
Common Device Name
GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11244426
Report Number1818910-2021-01996
Device Sequence Number19784790
Product Code KWS
UDI-Device Identifier10603295006985
UDI-Public10603295006985
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K981487
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/15/2021
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? Yes
Operator of Device Health Professional
Device Model Number1136-42-025
Device Catalogue Number113642025
Device Lot NumberBP1AF1000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/15/2021
Supplement Date Received by Manufacturer02/24/2021
Initial Report FDA Received Date01/28/2021
Supplement Report FDA Received Date02/25/2021
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
GLOBAL ADVANTAGE ECC HD 48X21; GLOBAL ADVANTAGE PC STEM 14MM; GLOBAL ANCHOR PEG GLENOID 48MM; GLOBAL ADVANTAGE ECC HD 48X21; GLOBAL ADVANTAGE PC STEM 14MM; GLOBAL ANCHOR PEG GLENOID 48MM
Outcome Attributed to Adverse Event Required Intervention;
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