MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number	113002000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2018
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
The patient was revised to address pain.Doi: (b)(6) 2013 dor: (b)(6) 2018 left shoulder.
Additional Manufacturer Narrative
(b)(4).Investigation summary: 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 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 AP 135 DEG TAPER ASSEM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7355145
• Report Number: 1818910-2018-55623
• Device Sequence Number: 11340849
• Product Code: HSD
• UDI-Device Identifier: 10603295005438
• UDI-Public: 10603295005438
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 02/28/2018

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: 113002000
• Device Lot Number: 353985
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/01/2018
• 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: 42 YR