MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 STEMLESS L 40; SHOULDER IMPLANT - HUMERAL ANCHOR

Model Number 5200-00-040

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

Patient Problem Joint Laxity (4526)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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's shoulder was not stable, needed to go to a reverse.Doi: (b)(6) 2019.Dor: (b)(6) 2023.Affected side: left shoulder.

• Brand Name: STEMLESS L 40
• Type of Device: SHOULDER IMPLANT - HUMERAL ANCHOR
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16297216
• MDR Text Key: 308781030
• Report Number: 1818910-2023-02812
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10603295538240
• UDI-Public: 10603295538240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203108
• 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
• Report Date: 02/03/2023

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 Model Number: 5200-00-040
• Device Catalogue Number: 520000040
• Device Lot Number: 177295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: ANATOMIC GLENOID XL 31.5; ANATOMIC OFFSET TAPER ADAPTER; HUMERAL HEAD 51X18; STEMLESS L 40
• Patient Outcome(s): Required Intervention