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

Catalog Number UNK SHOULDER HUMERAL HEAD

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

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Report source is a literature article.There is limited information regarding the reported death.(b)(4).

Event Description

"the literature article entitled ¿functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study¿ by tom r.Norris, md and joseph p.Iannotti, md, phd, published in the journal of shoulder and elbow surgery, volume 11, number 2, march/april 2002, was reviewed.The article¿s purpose is to report on a study that assess the outcome of arthroplasty for primary osteoarthritis two to seven years after surgery with a modular shoulder arthroplasty system.Between january 1991 and october 1993, 19 investigators at 17 clinical sites prospectively enrolled 176 consecutive shoulders in 160 patients with primary osteoarthritis of the glenohumeral joint in the study.The majority of shoulders underwent total shoulder arthroplasty (133) with the balance as hemiarthroplasty (43).Shoulder arthroplasty was performed in each case with the global modular shoulder prosthesis (depuy).Complications that were noted were: there were 10 intraoperative complications-nine of which were fractures.Four of those were periprosthetic fractures, two occurred in the glenoid rim, the other three were due to excessive rotation, inadequate exposure, and osteopenia.All but one were treated successfully intraoperatively, one required three procedures.Glenoid loosening and glenohumeral instability were the most common postoperative complications with tsa.Seven glenoid components were noted to be loose or shifted at a mean of 46 months after surgery.Four of these followed a shoulder impact fall which one of the pegs fractured in one patient.Four out of those seven had severe enough pain to perform a revision.One of the four failed glenoids had glenoid component loosening 60 months after the index arthroplasty.In three cases revised for glenoid loosening, there were polyethylene debris in the synovial tissue, one in an osteolytic lesion of the lesser tuberosity.In two, humeral stems were removed, changed to a smaller size and then cemented to prevent possible polyethylene-mediated osteolysis, in only one of these two did the pathology report confirm polyethylene debris down the humeral shaft.Five patients had postoperative humeral head subluxation or dislocation.Three of those were associated with a loose glenoid component, one also had a rotator cuff tear that was repaired at the time of revision.In the fourth case, it was associated with a postoperative subscapularis tendon tear.One patient had a rare complication of rupturing the anterior deltoid, which required rapid repair.His rotator cuff was intact and shoulder was stable.One patient died as the result of a pulmonary embolus in the immediate postoperative course of his staged bilateral replacement (three months after the contralateral replacement).".

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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 HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9341861
• MDR Text Key: 166990701
• Report Number: 1818910-2019-116830
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death