MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 52X15 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number 110052600

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.

• Brand Name: GLOBAL UNITE HEAD 52X15 ECC
• Type of Device: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18857366
• MDR Text Key: 337123258
• Report Number: 1818910-2024-05347
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004721
• UDI-Public: 10603295004721
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 110052600
• Device Lot Number: 527776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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; GLBL UNITE ANT BODY 135 SZ 14; GLOBAL UNITE STD STEM SZ 14
• Patient Outcome(s): Required Intervention