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

Model Number	1136-43-026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/09/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Subject id: (b)(6).Study: (b)(6).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).
Additional 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: CROSSLINK ANCHOR PG GLENOID 52
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• MDR Report Key: 12631394
• Report Number: 1818910-2021-22718
• Device Sequence Number: 11618341
• Product Code: KWS
• UDI-Device Identifier: 10603295007012
• UDI-Public: 10603295007012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1136-43-026
• Device Catalogue Number: 113643026
• Device Lot Number: HR2238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 87