MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 GLOBAL ADVANTAGE HUM HD 52X21; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Catalog Number	112852020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Not Applicable (3189)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient presented with painful right shoulder and possible infection.Operating surgeon suspects possible infection and loosening of the glenoid.Surgeon sent specimens for analysis.Removed glenoid with an instrument, bone grafted remaining glenoid and replaced numeral head.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # : (b)(4).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL ADVANTAGE HUM HD 52X21
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7392259
• Report Number: 1818910-2018-56587
• Device Sequence Number: 1092794
• Product Code: HSD
• UDI-Device Identifier: 10603295005216
• UDI-Public: 10603295005216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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 Number: 112852020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR