MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ANCHOR PLATE SIZE 44; SHOULDER HUMERAL STEM ACCESSORY

Model Number 1140-10-044

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

Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930)

Event Date 12/27/2020

Event Type  Injury  

Event Description

Clinical adverse event received for raised crp lab result.Event is not serious and is considered mild.Event is possibly related to device and is possibly related to procedure.Date of implantation: (b)(6) 2018; date of event (onset): (b)(6) 2020; (left shoulder).Treatment: none.

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.

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.Update 17-june-2022 received did not have any additional details to be added in investigation.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: ANCHOR PLATE SIZE 44
• Type of Device: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14713531
• MDR Text Key: 294160978
• Report Number: 1818910-2022-11019
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10603295381105
• UDI-Public: 10603295381105
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K212683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

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 Model Number: 1140-10-044
• Device Catalogue Number: 114010044
• Device Lot Number: 8614694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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 44; CROSSLINK ANCHOR PG GLENOID 40; HUMERAL HEAD SIZE 44
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG