MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE STEM 8 MM; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Model Number 1137-08-000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

Event Type  Injury  

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.

Event Description

Implants removed during revision - believed to be due to poor placement of humeral stem in too much anteversion.

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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL ADVANTAGE STEM 8 MM
• 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: 11827044
• MDR Text Key: 250816822
• Report Number: 1818910-2021-10361
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295007081
• UDI-Public: 10603295007081
• Combination Product (y/n): N
• PMA/PMN Number: K992065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1137-08-000
• Device Catalogue Number: 113708000
• Device Lot Number: YX8EY1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL ADVANTAGE STEM 8 MM; UNK SHOULDER HUMERAL HEAD GLOBAL
• Patient Outcome(s): Required Intervention