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

Catalog Number UNK SHOULDER HUMERAL STEM DELT

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

Patient Problems Ossification (1428); Hematoma (1884); Nerve Damage (1979); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.Literature citation: holschen m, körting m, khourdaji p, bockmann b, schulte tl, witt ka, steinbeck j.Treatment of proximal humerus fractures using reverse shoulder arthroplasty: do the inclination of the humeral component and the lateral offset of the glenosphere influence the clinical outcome and tuberosity healing? arch orthop trauma surg.2022 jan 3.Doi: 10.1007/s00402-021-04281-5.Epub ahead of print.Pmid: 34977963.Objective/methods/study data: for this retrospective comparative analysis, 58 out of 66 patients treated by reverse total shoulder arthroplasty for proximal humerus fractures were included.The minimum follow-up was 24 months.Thirty (m=3, f=27; mean age 78 years; mean fu 35 months, range 24¿58 months) were treated with a standard 155° humeral component and a glenosphere without lateral ofset (group a), while 28 patients (m=2, f=26; mean age 79 years; mean fu 30 months, range 24¿46 months) were treated with a 135° humeral component and a glenosphere with a 4 mm lateral offset (group b).Group a consisted of depuy xtend implants and group b were non depuy.This complaint captures the noted adverse events within group a.Cement manufacturer is not identified.Figure 4 is a radiographic image of a 77 year old female patient with implants, device manufacturer is not identified, and no adverse event noted.Figure 5 is a radiographic images of 80 year old female patient with implants, device manufacturer is not identified; noted is scapular notching and stress shielding at the proximal lateral diaphysis.Adverse event(s) and provided interventions: qty 1 minor neurologic complications with intermitting hypoesthesia occurred.Qty 1 hematoma requiring revision.Qty 1 joint instability requiring revision - treated with a larger inlay and remained stable after revision.Qty 14 scapular notching.Qty 2 radiolucency.Qty 1 stress shielding.Qty 2 heterotopic ossifications.

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 IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15138924
• MDR Text Key: 296973209
• Report Number: 1818910-2022-14613
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 STEM DELT
• 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