MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER GLENOSPHERE DELTA XTEND

Catalog Number UNK SHOULDER GLENOSPHERE DELTA

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.

Event Description

The literature article entitled, "delta xtend reverse shoulder arthroplasty ¿ results at a minimum of five years" written by craig m.Ball published by shoulder and elbow accepted by publisher 29 january 2019 was reviewed.The article's purpose was to review the clinical and radiographic outcomes of the delta xtend reverse shoulder arthroplasty at a minimum of five years.Data was compiled from 57 patients (59 shoulders) all implanted with delta xtend either uncemented modular stems or cemented monobloc between june 2007 and june 2012.Cement manufacturer is not identified.Figure 3 provides a radiographic image of a longer stem that replaced a primary delta xtend that was loose and associated with a fracture sequelae and proximal humeral bone loss.Adverse events: fracture sequelae with loose stem and proximal humeral bone loss (treated by revision to a longer stem, intraoperative calcar fracture (no treatment specified), axillary nerve palsy (listed a complication without recovery), minor transient neuropraxia of the thumb and index finger (resolved completely within 3-6 months and had no effect on clinical outcome), periprosthetic fracture of the metaglene post a fall (treated by revision), symptomatic notching with pain (treated by revision of glenosphere and liner exchange), stem subsidence (treatment not specified), cortical resorption (treatment not specified).

• Brand Name: UNK SHOULDER GLENOSPHERE DELTA XTEND
• Type of Device: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 10689810
• MDR Text Key: 216409102
• Report Number: 1818910-2020-22555
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention