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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL UNITE HEAD 48X18 STD; SHOULDER HUMERAL HEAD
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DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL UNITE HEAD 48X18 STD; SHOULDER HUMERAL HEAD Back to Search Results
Catalog Number 110048510
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/02/2017
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 infection.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
GLOBAL UNITE HEAD 48X18 STD
Common Device Name
SHOULDER HUMERAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7068937
Report Number1818910-2017-50398
Device Sequence Number101764
Product Code HSD
UDI-Device Identifier10603295004585
UDI-Public10603295004585
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K101996
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 11/02/2017
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 Catalogue Number110048510
Device Lot NumberH47203
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/02/2017
Supplement Date Received by Manufacturer03/05/2018
Initial Report FDA Received Date11/29/2017
Supplement Report FDA Received Date03/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age67 YR
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