MAUDE Adverse Event Report: HUMERAL HEAD SIZE 54; SHOULDER HUMERAL HEADS

Catalog Number 114020054

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

Patient Problem Arrhythmia (1721)

Event Date 06/09/2019

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

Subject id: (b)(6).Study: (b)(4).Clinical adverse event received for paroxysmal atrial fibrillation.Event is serious and is considered severe.Event is definitely not related to device and there is a remote possibility the event is related to procedure.Date of implantation: (b)(6) 2018.Date of event (onset): (b)(6) 2019.(left shoulder).Treatment: hospitalization with medical intervention (unspecified).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: HUMERAL HEAD SIZE 54
• Type of Device: SHOULDER HUMERAL HEADS
• MDR Report Key: 12631397
• MDR Text Key: 276358086
• Report Number: 1818910-2021-22717
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295381280
• UDI-Public: 10603295381280
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114020054
• Device Lot Number: HD4651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANCHOR PLATE SIZE 54; CROSSLINK ANCHOR PG GLENOID 52; HUMERAL HEAD SIZE 54; ANCHOR PLATE SIZE 54; CROSSLINK ANCHOR PG GLENOID 52; HUMERAL HEAD SIZE 54
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 87