MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE STEM 12 MM; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Catalog Number	113712000
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	11/02/2018
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.(b)(4).
Event or Problem Description
The patient was revised to address loosening of humeral stem at bone to implant interface.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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 12 MM
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8105420
• Report Number: 1818910-2018-76339
• Device Sequence Number: 19307890
• Product Code: KWS
• UDI-Device Identifier: 10603295007142
• UDI-Public: 10603295007142
• 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): 11/02/2018

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: 113712000
• Device Lot Number: D16101210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/10/2018
• 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