MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

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

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.[(b)(4)].

Event Description

The literature article entitled ¿clinical and radiographic outcomes of the ream-and-run procedure for primary glenohumeral arthritis¿ written by jeremy s.Somerson, md, et al., published in the journal of bone and joint surgery, august 2, 2017, was reviewed.The purpose of the study was to answer the following two questions: (1) what factors were associated with the amount of medialization of the humeral head relative to the scapula after the ream-and-run procedure? (2) to what degree were the clinical outcomes after the ream-and-run procedure associated with the amount of postoperative medialization? the study analyzed 150 shoulders that had a ream-and-run shoulder arthroplasty between august 24, 2010 and october 22, 2013.The prosthesis used was the global advantage (depuy) and was secured using impaction autografting with bone harvested from the resected humeral head.132 patients (132 shoulders) consented to the study.Two-year clinical outcomes were available for 120 of these shoulders.Fourteen shoulders underwent subsequent procedures.Four patients underwent closed manipulation under anesthesia for persistent stiffness.Seven patients underwent single stage exchange of the humeral component and soft-tissue releases because of pain and stiffness; six of them had cultures positive for propionibacterium at the time of revision.Three patients had revision to total shoulder arthroplasty (one culture was positive for propionibacterium, and one revision was performed at an outside institution without culture data available).

Manufacturer Narrative

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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9429203
• MDR Text Key: 187120515
• Report Number: 1818910-2019-118866
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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 STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention