MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ANATOMIC GLENOID S 24; SHOULDER IMPLANT - GLENOID

Catalog Number 510024000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 08/04/2023

Event Type  Injury  

Event Description

Patient was converted to a reverse shoulder as the surgeon stated that he believed the patient tore her rc during therapy and made the joint unstable and was rocking the glenoid implant and it loosened and became dislodged.Loosening of the glenoid component at the bone to cement interface was reported.There was no surgical delay.Doi: (b)(6) 2023, dor:(b)(6) 2023 affected side: left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: ANATOMIC GLENOID S 24
• Type of Device: SHOULDER IMPLANT - GLENOID
• 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: 17606866
• MDR Text Key: 321778794
• Report Number: 1818910-2023-17301
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 10603295538158
• UDI-Public: 10603295538158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202716
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 510024000
• Device Lot Number: MI118663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 OFFSET TAPER ADAPTER.; DEPUY/CMW 2G.; HUMERAL HEAD 48.5X19.5.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 78 KG