MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP

Catalog Number UNK HUMERAL CUP DELTA

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

Patient Problems Unspecified Infection (1930); Injury (2348); No Code Available (3191)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "reverse shoulder arthroplasty for rheumatoid arthritis since the introduction of disease-modifying drugs" written by devin r.Mangold, eric r.Wagner, robert h.Cofield, joaquin sanchez-sotelo, and john w.Sperling published by international orthopaedics and published online 26 july 2019 was reviewed.The article's purpose was to retrospectively review clinical and radiographic outcomes of patients who underwent reverse shoulder arthroplasty for rheumatoid arthritis and other inflammatory arthropathies and provide a comprehensive analysis to identify factors that may alter patient outcomes.Data was compiled form 75 patients who received primary rsas between 2006 to 2013 and had at least a two year follow up.Depuy products were listed amongst non-depuy products within the study.Article reports some humeral components were cemented but does not specify the manufacturer of the cement, nor does it identify which manufacturer implants were cemented other than anatomical location of humerus.The article also does not identify specific products relating to specific adverse events.All figures provide radiographic images for illustrative purposes and does not identify products or manufacturers of captured implants.Depuy product: delta iii and delta xtend constructs.Generalized adverse events: intraoperative humeral fracture occurring during implantation (treatment not specified) post op humeral displaced fracture involving "press-fit humeral component" (treated by revision).Deep periprosthetic infection (treated with surgical irrigation and debridement and components retained).Glenoid component loosening (both patients had minimal symptoms and did not wish to undergo revision surgery - no treatment, no further details provided on "loosening") radiographic detection of scapular notching (no treatment provided).

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.

• Brand Name: UNK SHOULDER HUMERAL CUP
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10614571
• MDR Text Key: 209775852
• Report Number: 1818910-2020-21421
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HUMERAL CUP DELTA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention