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

Catalog Number UNK SHOULDER GLENOSPHERE DELTA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/01/2020

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, "salvage reverse total shoulder arthroplasty for failed operative treatment of proximal humeral fractures in patients younger than 60 years: long-term results" written by lukas ernstbrunner, md, phd, stefan rahm, md, aline suter, md, mohamed a.Imam, md, phd, sabrina catanzaro, rn, florian grubhofer, md, and christian gerber, md published by the journal of shoulder and elbow surgery 2020 was reviewed.The article's purpose analyze whether salvage rtsa (reverse total shoulder arthroplasty) for failed orif or hemiarthroplasty for complex proximal humeral fractures in patients younger than 60 years is associated with a worthwhile long-term improvement in pain and function and absence of complications outweighing the risks of the procedure.Data was compiled from 38 patients (24 women and 14 men) with mean age of 52 years.Depuy products were listed amongst the products identified for the salvage rtsa procedure.Figure 1a-b and figure 2b provide radiographic images without identifying products for illustrative purposes.Figure 2a provides photographic image of a component without identification for illustrative purposes.Depuy products: delta iii reverse shoulder construction.Adverse events: acromial fracture (conservative treatment).Persistent pain (treated by arthroscopic debridement).Mechanical block (treated by resection of inferior glenoid osteophyte and exchange of metaphysis and liner).Metallosis (treated by exchange of metaphysis and liner).Pseudo paralysis of er (treated by latissimus dorsi transfer).Late dislocation (treated by closed reduction and/or open reduction and epiphyseal augmentation).Periprosthetic humeral fracture (treated by conservative treatment and/or orif).Loss of shoulder function (treated by conversion to hemiarthroplasty).Glenoid loosening (treated by conversion to hemiarthroplasty).Infection (treated by exchange of rtsa, exchange of loose shaft, antibiotic treatment and or cement spacer insertion).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: UNK SHOULDER GLENOSPHERE DELTA XTEND
• Type of Device: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10622931
• MDR Text Key: 215104300
• Report Number: 1818910-2020-21548
• 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: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE DELTA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention