MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 GLOBAL ADVANTAGE STEM 8 LONG; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Catalog Number	113708010
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2018
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
It was reported that the humeral head is changed due to previous humeral fracture.
Additional Manufacturer Narrative
(b)(4).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 will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL ADVANTAGE STEM 8 LONG
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8048171
• Report Number: 1818910-2018-74888
• Device Sequence Number: 11131008
• Product Code: HSD
• UDI-Device Identifier: 10603295007098
• UDI-Public: 10603295007098
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K992065
• 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): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 113708010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention