MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE PC STEM 10MM; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Model Number 1137-10-050

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 02/19/2020

Event Type  Injury  

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 Description

The patient was revised to address infection and loosening of the humeral head.He was taken to the or today for removal of implants, i&d, and placement of antibiotic spacer.No other information.Doi: unknown; dor: (b)(6) 2020; right shoulder.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (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 ADVANTAGE PC STEM 10MM
• Type of Device: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9815011
• MDR Text Key: 183100766
• Report Number: 1818910-2020-07414
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 10603295007135
• UDI-Public: 10603295007135
• Combination Product (y/n): N
• PMA/PMN Number: K011047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1137-10-050
• Device Catalogue Number: 113710050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR