MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 52; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Catalog Number 113643026

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

Patient Problems Atrial Fibrillation (1729); Pneumonia (2011)

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

Clinical adverse event received for pneumonia and paroxysmal atrial fibrillation.Event is serious and is considered severe.Event is definitely not related to device and probably related to procedure.Date of implant: (b)(6) 2018.Date of event: (b)(6) 2019.(left shoulder).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint #: (b)(4).Investigation summary: no device was received.Root cause undetermined.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 52
• Type of Device: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8932260
• MDR Text Key: 155659775
• Report Number: 1818910-2019-102215
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295007012
• UDI-Public: 10603295007012
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113643026
• Device Lot Number: HR2238
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 87