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

Catalog Number UNK SHOULDER HUMERAL EPIPHYSIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

Article entitled "comparative study of 145 onlay curved stem versus 155 inlay straight stem reverse shoulder arthroplasty: clinical and radiographic results with a minimum 2-year follow-up" written by matthew c.Giordano, md, katia corona, md, brent j.Morris, md, fabrizio mocini, md, luca saturnino, md, and simone cerciello, md published in journal of shoulder and elbow surgery in 2022 was reviewed.The aim of the present study was to compare clinical and radiographic results of a new curved 145 onlay design with a traditional straight 155 inlay design in patients undergoing primary rsa.Study included 76 patients who underwent an rsa between march 2013 to may 2019.42 patients were implanted with a long straight inlay stem with a 155 nsa (delta xtend rsa system).30/42 patient had cemented stems ¿ cement mfg is unknown.Adverse events related to delta xtend: 1 patient had a local infection, which required surgical d debridement.1 dislocation, which required revision surgery after 2 months.10 patients had scapular notching per radiographs¿ no treatment noted.3 patients had cortical thinning per radiographs¿ no treatment noted.7 patients had calcar osteolysis per radiographs¿ no treatment noted.Radiolucency (1 for humeral and 6 for glenoid) ¿ no confirmed through revision.

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 EPIPHYSIS DELTA XTEND
• Type of Device: SHOULDER HUMERAL EPIPHYSIS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15139728
• MDR Text Key: 296986650
• Report Number: 1818910-2022-14632
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL EPIPHYSIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• 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