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

Catalog Number UNK SHOULDER HUMERAL

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Muscular Rigidity (1968); Nerve Damage (1979); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

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

Literature article entitled "long-term impact of scapular notching after reverse shoulder arthroplasty¿ written by c.Spiry, j.Berhouet & c.Agout, g.Bacle, luc favard; published by international orthopaedics published online 16 march 2021was reviewed.The article's purpose ¿sought to determine how scapular notching changes over time and how it impacts shoulder function and the glenoid implant¿.Patient data: between 1993 and 2006, 81 patients (91 shoulders) underwent rsa for primary glenohumeral osteoarthritis or massive cuff tear with or without osteoarthritis.There were 67 women and 14 men.All patients were operated upon in the beach chair position.The deltopectoral approach was used in 72 shoulders and the anterosuperior approach in 19 shoulders.The delta reverse shoulder system (depuy, warsaw, in) was used in 40 shoulders and the competitor aequalis reverse shoulder system was used in 51 shoulders; both implants had exactly the same design with 155° humeral cup/head inclination.The humeral stem was cemented in 29 shoulders.Cement manufacturer not provided.The glenoid baseplate was never cemented.All glenospheres were 36 mm in diameter.The pe insert was lateralized in 80 shoulders and standard in 11 shoulders.Depuy products: delta reverse shoulder system adverse events: instability, infection, periprosthetic humeral fractures, aseptic glenoid loosening, partial glenoid disassembly, humeral loosening, stiffness, scapular notching, ulnar nerve compression, irrigation and debridement, orif, device revision and replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this reported event was not returned.Available xray evidence included in the study was reviewed.No failure of any depuy product can be observed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNK SHOULDER HUMERAL STEM DELTA XTEND
• Type of Device: SHOULDER HUMERAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12420867
• MDR Text Key: 269762819
• Report Number: 1818910-2021-19264
• 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: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention