MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE HUMERAL SHELL S 32+0; SHOULDER IMPLANT - HUMERAL HEAD

Catalog Number 550000320

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

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had her shoulder replaced approximately a year ago and have an inhance reverse shoulder implanted.Patient came to doctor because of shoulder pain.After trying other non-surgical treatments the decision was made to revise the shoulder to find the pain source.During the revision procedure scar tissue was excised, the components were well fixed, and test for infection came back negative.The humeral tray and poly were explanted and new components were replaced.Doi: approximately a year ago dor: (b)(6), 2023 affected side: right shoulder.

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: REVERSE HUMERAL SHELL S 32+0
• Type of Device: SHOULDER IMPLANT - HUMERAL HEAD
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17540023
• MDR Text Key: 321053759
• Report Number: 1818910-2023-16650
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295547006
• UDI-Public: 10603295547006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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: 550000320
• Device Lot Number: 178881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: REVERSE LINER 32+0
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female