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

Catalog Number UNK SHOULDER HUMERAL STEM DELT

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Insufficient Information (4580)

Event Date 06/02/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: doany me, ling k, jeong r, nazemi a, komatsu de, wang ed.Comparison of early range of motion in reverse shoulder arthroplasty based on indication: a single center retrospective review.J shoulder elb arthroplast.2022 jun 14;6:24715492221108283.Doi: 10.1177/24715492221108283.Pmid: 35719846; pmcid: pmc9203724.Objective and methods: authors conducted a retrospective analysis of all reverse shoulder arthroplasties (rsa) (1 jan 2000 thru 31 dec 2018), grouping patients by indication into ¿traumatic¿ and ¿non-traumatic elective¿ groups.The purpose was to compare early active range of motion (arom) of the affected shoulder for both groups.Depuy delta xtend system was used (from 2000 thru 2016), along with a competitor shoulder system (2016-2018).Authors did not break out data into individual patients, such as by case number or age/gender demographics.Results: 367 rsa procedures were performed, 88 for fracture, and 279 for non-traumatic elective indication.Forward elevation and external rotation arom were inferior in the fracture group at all visits in the first two years.Internal rotation arom was equivalent though.Final shoulder survey and patient satisfaction scores were statistically equivalent, though, in the fracture and non-fracture groups.Complications: three revisions occurred in each group.In the fracture group, two were for instability with dislocation, and one was for infection.In the non-fracture group, two were for acromial fractures, and one was for aseptic loosening of the humeral component.Fracture group: 2: shoulders revised to treat instability and dislocation (specifics not provided).1: shoulder was revised to address infection (specifics not provided).Non-fracture group: 2: shoulders revised to address acromial bone fractures (specifics not provided).1: shoulder revised to address aseptic loosening of the humeral component (specifics not provided).

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 STEM DELTA XTEND
• Type of Device: SHOULDER HUMERAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15173957
• MDR Text Key: 297318347
• Report Number: 1818910-2022-15168
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• 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: 08/11/2022
• 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