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

Catalog Number UNK SHOULDER HUMERAL STEM DELT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Hematoma (1884); Unspecified Mental, Emotional or Behavioural Problem (4430); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 ¿reversed shoulder arthroplasty in cuff tear arthritis, fracture sequelae, and revision arthroplasty - outcome in 59 patients followed for 2¿7 years"" written by annika stechel, uwe fuhrmann, lars irlenbusch, olaf rott, and ulrich irlenbusch; published by acta orthopaedica published online/accepted by publisher 01 feb 2010 was reviewed.The article's purpose was to ¿analyze the medium¿term results and potential complications of the reversed prostheses, and also the influence of etiology on the result.¿ patient data: 68 consecutive shoulders with a reversed delta iii prosthesis (depuy) during the period 2002 ¿ 2007.59 patients (52 women) with an average age of 70 (60¿82) years participated in this study and they were followed prospectively for mean 4 (2¿7) years.The indications were cuff tear arthropathy (cta) in 23 patients, fracture sequelae in 20 patients, and revision of a conventional prosthesis (unknown manufacturer) in 16 patients.Depuy products: delta iii reverse.Adverse events: scapular notching (51).Lysis observed below the baseplate (2).Infection (5).Hematoma (5).Heterotopic ossifications (14).Acromion fracture (1).Coracoid process fracture (1).Transient neurological deficits (2).Dislocation (3).Disassociation stem and epiphysis (2).Device revision or replacement (15).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this reported event was not returned.The investigation could not draw any conclusions about the reported event without the device to examine.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 or product code 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: 12484989
• MDR Text Key: 272300298
• Report Number: 1818910-2021-20333
• 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
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM DELT
• 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