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

Catalog Number 113712000

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

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> pc (b)(4).Patient code: no code available (3191) used to capture the device revision or replacement, joint injury and joint instability.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 cuff tear, instability and limited motion.Converted to reverse shoulder.Doi: unknown, dor: (b)(6) 2020, left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GLOBAL ADVANTAGE STEM 12 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: 10673074
• MDR Text Key: 211261396
• Report Number: 1818910-2020-22214
• Device Sequence Number: 1
• Product Code: HSD
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113712000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK SHOULDER HUMERAL HEAD GLOBAL
• Patient Outcome(s): Required Intervention