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

Catalog Number UNK HUMERAL STEM DELT

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Joint Laxity (4526)

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

This complaint is from a literature source.Literature citation: hornung s, reiter g, grützner pa, gühring t.Two-stage shoulder arthroplasty after deep infection of the shoulder caused by arthroplasty, osteosynthesis or other surgical procedures: microbial spectrum, complications and functional outcome after at least 1 year follow-up.Arch orthop trauma surg.2021 aug 25.Doi: 10.1007/s00402-021-04129-y.Epub ahead of print.Pmid: 34432098.Objective/methods/study data: retrospective cohort study, we included patients (n=26) with a deep infection of the shoulder after arthroplasties, osteosynthesis, rotator cuff repair or shoulder empyema without any surgical procedure treated with a two-stage shoulder arthroplasty from april 2013 to may 2020.The implants used in the 26 cases consisted of 23 cases using depuy delta xtend and the other two cases were non-depuy (qty 2 aequalis ascend flex by tornier and qty 1 mutars by implantcast).Of these initial 26 patients, 16 patients could be included in the 1 year follow-up analysis.The article does not provide quantities of each manufacturer for the 16 patients.It is noted that of the 26 original cohort, 13 are categorized as the shoulder arthroplasty implant is the cause of the infection; and then of the 16 follow up group it is reduced to 9.It is also noted that some patients received trauma products (medical device manufacturer not identified).Table 6 provides a distribution of complications and revisions captured for each case for the original cohort but the article does not identify the specific medical device manufacturer for each case.Therefore, exact quantities cannot be determined and adverse events can only be surmised by the limited information provided by the article.Adverse event(s) and provided interventions (at least qty 1 will be captured of the follow summarized adverse event: total qty 13 deep infections attributed to shoulder arthroplasty: qty 6 shoulder dislocations - all treated with revisions.Qty 5 hematomas - 4 of these cases treated operatively.

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: 15138455
• MDR Text Key: 296964611
• Report Number: 1818910-2022-14578
• 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 HUMERAL STEM DELT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2022
• 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