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

Catalog Number UNK SHOULDER HUMERAL EPIPHYSIS

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Article entitled "good long-term patient-reported outcome after shoulder arthroplasty for cuff tear arthropathy" written by karoline p.Nielsen, md, alexander amundsen, md, phd, bo s.Olsen, md, phd, and jeppe v.Rasmussen, md, phd published in jses international in 2022 was reviewed.The purpose of this prospective registry study was to report the long-term patient-reported outcome of ha and rsa in patients with cta.We hypothesized that the long-term outcome of the two arthroplasties types would be in favor of rsa.The study included a total of 120 shoulders (42 ha and 78 rsa) (116 patients).At the final follow-up, the rsa group included 20 (26%) delta iii (depuy, warsaw, in, usa) arthroplasties and 45 (58%) delta xtend (depuy) arthroplasties.The ha group included 18 (43%) copeland resurfacing arthroplasties (biomet, warsaw, indiana) and 10 (24%) global advantage stemmed arthroplasties (depuy).Adverse events involving depuy synthes implants: two ha patients with global advantage were revised ¿ unknown reason for revision.Four rsa patients with delta iii were revised.One for loosening (unknown component), 2 for infection, and one for unknown reason for revision.One rsa patient with delta xtend was revised ¿ unknown reason for revision.

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.

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: 15052439
• MDR Text Key: 296139987
• Report Number: 1818910-2022-13380
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 07/19/2022

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 EPIPHYSIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 07/26/2022
• 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