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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 12 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
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DEPUY ORTHOPAEDICS INC US GLOBAL AP PC STEM 12 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS Back to Search Results
Catalog Number 113012200
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Pain (1994); Not Applicable (3189)
Date of Event 07/13/2018
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
The patient was revised to address painful shoulder.Doi: unk; dor: (b)(6) 2018; unknown shoulder.
 
Additional Manufacturer Narrative
Pc(b)(4).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 AP PC STEM 12 MM
Common Device Name
GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7767541
Report Number1818910-2018-66225
Device Sequence Number16200315
Product Code KWS
UDI-Device Identifier10603295005544
UDI-Public10603295005544
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K063652
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/16/2018
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 Number113012200
Device Lot Number552835
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/16/2018
Supplement Date Received by Manufacturer08/28/2018
Initial Report FDA Received Date08/09/2018
Supplement Report FDA Received Date08/31/2018
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;
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