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

Catalog Number UNK SHOULDER HUM STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 12/26/2019

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, "what factors are associated with revision or worse patient-reported outcome after reverse shoulder arthroplasty for cuff-tear arthropathy? a study from the danish shoulder arthroplasty registry" published by clinical orthopaedics and related research published online on 26 december 2019 was reviewed.The article's purpose was to examine 10 year cumulative revision rate after reverse shoulder arthroplasty for cuff-tear arthropathy to determine risk factors associated with risk of revision, and the article reports on outcomes 1 year post surgery with factors associated with a worse patient-reported outcome.Data was compiled from the danish shoulder arthroplasty registry with patients treated from 2006 to 2015.Depuy products were listed among the products utilized encompassing the majority percentage but not accounting for entire data set.Article provides summarized reasons for revisions without detail or specifics.Depuy products: delta xtend and delta mark iii constructs.Reasons for revision for depuy products: implant dislocation, infection, loosening (no details provided), technical failure (no further details).

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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: UNK SHOULDER HUMERAL STEM
• Type of Device: SHOULDER HUMERAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10645143
• MDR Text Key: 210371305
• Report Number: 1818910-2020-21749
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUM STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention