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

Catalog Number UNK SHOULDER HUMERAL EPIPHYSIS

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Article entitled ¿rehabilitation progress following reverse total shoulder replacement and internal fixation for geriatric three and four-part proximal humerus fractures ¿ a propensity score matched comparison¿ written by chi him tong and christian xinshuo fang published in bmc "musculoskeletal" disorders in 2023 as reviewed.The purpose of this study is to evaluate and compare the early and mid-term rehabilitation progress in geriatric patients with 3-part and 4-part proximal humerus fractures after rtsa versus orif.Rtsa were implanted in 25 patients.21 patients were implanted with delta xtend and 4 were implanted with competitor.Results (no specific to depuy synthes): adverse event(s) that are possibly associated with unk - humeral stem 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.Adverse event(s) that are possibly associated with unk - metaglene 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.Adverse event(s) that are possibly associated with unk - locking screw 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.Adverse event(s) that are possibly associated with unk - locking screw 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.Adverse event(s) that are possibly associated with unk -glenosphere 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.Adverse event(s) that are possibly associated with unk - epiphysis 5 patients with tuberosity non-union.No treatment indicated 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.Adverse event(s) that are possibly associated with unk -humeral cup 3 patients observed to have scapular notching.No treatment indicated 1 patient developed post-operative wound infection, which settled after debridement, antibiotics and retention of implants.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19179737
• MDR Text Key: 341007211
• Report Number: 1818910-2024-09049
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL EPIPHYSIS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2024
• Initial Date FDA Received: 04/25/2024
• 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