MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL C.A.P. HEAD HA 40X15; GLOBAL CAP IMPLANT : SHOULDER HUMERAL HEADS

Model Number 1230-40-005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/11/2020

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

The patient was revised to address glenoid erosion.Doi: unknown, dor: (b)(6) 2020, right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: GLOBAL C.A.P. HEAD HA 40X15
• Type of Device: GLOBAL CAP IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10449853
• MDR Text Key: 204250893
• Report Number: 1818910-2020-18722
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295017691
• UDI-Public: 10603295017691
• Combination Product (y/n): N
• PMA/PMN Number: K033516
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1230-40-005
• Device Catalogue Number: 123040005
• Device Lot Number: ED9VE1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention