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

Catalog Number UNK SHOULDER HUMERAL CUP DELTA

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); 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 " reverse shoulder arthroplasty in complex fractures of the proximal humerus: results after 7 years of follow up" written by alberto izquierdo fernández, marta gómez rodríguez, maite urbano luque, manuel garcía carmona, rafael quevedo reinoso, and josé carlos minarro published in journal of orthopaedics and truamatology in 2021 was reviewed.The aim of this paper was to evaluate the medium-term functional activity of complex fractures of the proximal humerus treated by a reverse shoulder prosthesis.Study included 32 patients who had a stem-cemented delta xtend reverse prosthesis system.Cement manufacturer is unknown.Adverse events: eight of the 32 patients had scapular notching.No treatment noted.One humeral periprosthetic fracture (treated with osteosynthesis).One prosthetic dislocation (resolved through closed reduction with no need for replacement).No signs of component loosening were reported on follow-up control radiographs.

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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15138517
• MDR Text Key: 296966200
• Report Number: 1818910-2022-14595
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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?: 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
• Date Manufacturer Received: 08/25/2022
• 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