MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Catalog Number 110050000

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

Revision of total shoulder replacement - converted to reverse shoulder due to rotator cuff failure causing pain and reduced function.Right shoulder all components explanted and replaced with reverse shoulder.Doi: (b)(6) 2022 doe: (b)(6) 2024.

Manufacturer Narrative

Product complaint(b)(4).Investigation summary revision of total shoulder replacement - converted to reverse shoulder due to rotator cuff failure causing pain and reduced function.Right shoulder all components explanted and replaced with reverse shoulder ¿the product was not returned to depuy synthes, however photos were provided for review.See attachment [img_9504.Jpeg].The x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the glbl unite ant body 135 sz 14 would not contribute to the reported adverse event based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing record evaluation was performed for the finished device 110050000/9655098 global unite ant body 135 sz14 (17 parts) was manufactured on 04-dec-2020: parts were manufactured per specification and all raw materials met specification.Device history review a manufacturing record evaluation was performed for the finished device 110050000/9655098 global unite ant body 135 sz14 (17 parts) was manufactured on 04-dec-2020: parts were manufactured per specification and all raw materials met specification.

• Brand Name: GLBL UNITE ANT BODY 135 SZ 14
• Type of Device: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18857363
• MDR Text Key: 337123225
• Report Number: 1818910-2024-05345
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004639
• UDI-Public: 10603295004639
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: 110050000
• Device Lot Number: 9655098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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: CROSSLINK ANCHOR PG GLENOID 52.; GLOBAL UNITE HEAD 52X15 ECC.; GLOBAL UNITE STD STEM SZ 14.
• Patient Outcome(s): Required Intervention