MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL ADVANTAGE HUM HD 56X18; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Catalog Number	112856010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	08/07/2018
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.Concomitant medical products: global advantage hum hd 56x18 humeral head component; unknown shoulder humeral stem component.
Event or Problem Description
It was reported that there was an unknown increased pain over years of implanted hemiarthroplasty.Doi: unknown; dor: (b)(6) 2018; left shoulder.
Additional Manufacturer Narrative
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, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL ADVANTAGE HUM HD 56X18
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7841656
• Report Number: 1818910-2018-68305
• Device Sequence Number: 11250427
• Product Code: HSD
• UDI-Device Identifier: 10603295005254
• UDI-Public: 10603295005254
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: 112856010
• Device Lot Number: EPA461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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