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

Catalog Number UNK SHOULDER HUMERAL CUP DELTA

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Literature article reviewed.Mahylis jm, puzzitiello rn, ho jc, amini mh, iannotti jp, ricchetti et.Comparison of radiographic and clinical outcomes of revision reverse total shoulder arthroplasty with structural versus nonstructural bone graft.J shoulder elbow surg.28 jan 2019.Pmid: 30201217.The article's purpose was to compare radiographic and clinical results of patients requiring structural iliac crest bone autograft (icba) for severe bone loss versus patients with less severe bone loss treated with nonstructural bone allograft (nsba) in the setting of revision reverse total shoulder arthroplasty (rsa).Patient data: 67.4 mean age, 46.6% female.Depuy products: depuy delta xtend in 21 patients, competitor constructs were also utilized in 9 patients.Adverse events (n = number of impacted patients is not clear within the article): (n) metaglene malpositioning ¿ treatment not noted, (n) scapular notching ¿ treatment not noted, (1) shoulder dislocation ¿ closed reduction, (2) glenoid baseplate migration ¿ conservative treatment, (1) glenoid loosening ¿ treatment not noted, (1) infection ¿ 2 stage revision.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER HUMERAL CUP DELTA XTEND
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15542458
• MDR Text Key: 301162360
• Report Number: 1818910-2022-19571
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL CUP DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention