MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER METAGLENE

Catalog Number UNK SHOULDER METAGLENE

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

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 07/11/2017

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Report source is a literature article.There is limited information regarding the reported death.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 ¿what are the complications, survival, and outcomes after revision to reverse shoulder arthroplasty in patients older than 80 years?¿, by eduard alentorn-geli, md, et al; published in the clinical orthopaedics and related research, july 11, 2017.The purpose of the article was to cover the questions of: what are the 90-day medical and surgical complications after revision to reverse shoulder arthroplasty (rsa) in patients older than 80 years? what are the 2-and 5-year survival rates after revision? was there an improvement in pain at rest or with activity range of motion (rom), and strength after revision surgery? between 2004 and 2013, 38 patients who were older than 80 years underwent revision surgery to a rsa.Of those, five were lost to follow-up before two years, and two had died within two years of revision surgery, leaving 31 for analysis of our survivorship, pain, rom, and strength endpoints at a minimum of two years or until revision surgery had occurred; all 38 patients were included for purposes of evaluating medical and surgical complications at 90 days.Medical complications occurred in three of 38 patients and surgical complications occurred in five of 38 patients.The 90-day mortality was 3% (one in 38 patients).The cumulative incidence of revision was 11% at two years and 16% at five years.Pain at rest or with activity improved from pre to post operation.The authors conclude that age should not be a reason to no consider revision surgery to rsa in patients older than 80 years.There were multiple prosthesis systems used, with only three of them being the delta reverse shoulder system (depuy).The article did not specify which prosthesis had complications.Medical complications included pneumonia in one patient, uti in one patient, and stroke in one patient.Surgical complications included glenoid loosening in three patients, deep infection with humeral component loosening in one patient, component dissociation in one patient.Five patients required reoperations due to glenoid loosening (at two, nine and 15 months) after the index procedure; reoperations due to deep infection and component dissociation occurred at 35 months and at one month after the index procedure.There were no cases of scapular notching.Pain and active rom increased after operation.In this study, only one patient died during the first 90 days due to a stroke after one month.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthese 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9410548
• MDR Text Key: 169074214
• Report Number: 1818910-2019-118709
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER METAGLENE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death