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

Catalog Number UNK HUMERAL EPIPHYSIS

Device Problem Osseointegration Problem (3003)

Patient Problems Sepsis (2067); Inadequate Osseointegration (2646)

Event Date 08/24/2020

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

An article/literature was received entitled " stable glenoid component of reverse total shoulder arthroplasty at 2 years as measured with model-based radiostereometric analysis (rsa)".Literature article entitled "stable glenoid component of reverse total shoulder arthroplasty at 2 years as measured with model-based radiostereometric analysis (rsa)" written by alexander nilsskog fraser, berte bøe, tore fjalestad, jan erik madsen and stephan m röhrl.Published by acta orthopaedica published online/accepted by publisher 1 jul 2021 was reviewed.The article's purpose was to follow 20 patients and assess stability of the glenoid component in reverse tsa, using model-based rsa.The 20 patients received primary treatment with a reversed tsa using a delta xtend shoulder.Specific patient identifiers were not given in the article.X-ray and ct images can be found on pages 3 and 4 of the literature article.Depuy products with known adverse event(s): metaglene x 2.Locking screw x 4.Glenosphere.Humeral cup.Humeral epiphysis.Humeral stem.Adverse events: migration of the metaglene with no indicated treatment.Humeral cup notching with no indicated treatment.Septic loosening with revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and evidence of shoulder metaglenes and shoulder screws migration was found.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
• Type of Device: SHOULDER HUMERAL EPIPHYSIS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12437084
• MDR Text Key: 270869577
• Report Number: 1818910-2021-19511
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HUMERAL EPIPHYSIS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention