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

Catalog Number UNK SHOULDER HUMERAL STEM DELT

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 01/01/2017

Event Type  Injury  

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.

Event Description

Article entitled ¿reverse shoulder arthroplasty compared with hemiarthroplasty in the treatment of acute proximal humeral fractures¿ written by michael van der merwe, mbc, matthew j.Boyle, bs, mbchb, fracs, christopher m.A.Frampton, phd, and craig m.Ball, mbchb, fracs published in journal of shoulder and elbow surgery in 2017 was reviewed.The aim of this study was to provide an update to the previous paper of boyle et al by comparing the functional outcomes of rsa with hemiarthroplasty in the management of acute proximal humeral fractures.Among rsa patients, the most used prostheses were the smr modular shoulder (limacorporate s.P.A., udine, italy; used in 117 patients) and the delta xtend reverse shoulder system (depuy, warsaw, in, usa; used in 81 patients).Among hemiarthroplasty patients, the most used prostheses were the global (depuy; used in 210 patients), the global advantage humeral head (depuy; used in 197 patients), and the smr (used in 75 patients).It is unknown if the humeral stems were cemented or porous coated.Adverse events aren¿t specific to the depuy implants- the reasons for revision recorded by the new zealand joint registry included deep infection, pain, dislocation, fracture, implant loosening or failure, cuff tear, and stiffness.

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 STEM DELTA XTEND
• Type of Device: SHOULDER HUMERAL STEM
• 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: 15525997
• MDR Text Key: 301007187
• Report Number: 1818910-2022-19276
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM DELT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• 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