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

Catalog Number UNK SHOULDER GLENOSPHERE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 10/21/2015

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 ¿glenoid bone grafting in revision to a reverse total shoulder arthroplasty¿, written by eric wagner, md, et al, published in the journal of bone and joint surgery, volume 97-a, number 20 on october 21, 2015; was reviewed.The purpose of the article was to review the outcomes associated with glenoid bone-grafting in the setting of revision to a reverse shoulder arthroplasty.Specifically, we aimed to analyze the overall success and identify any factors that might predict worse outcomes.Between 2005 and 2010, 143 consecutive revision shoulder arthroplasties with implantation of a reverse shoulder replacement were performed at our institution.Glenoid bone grafting was performed in 41 of those shoulders.40 shoulders were followed for an average of 3.1 years (2-6 years) or until revision surgery; one patient was excluded for having less than two years follow-up.Four different implant systems were used; the delta iii (1) and the delta xtend (7), and two other implants that were competitor products.Of the 40 shoulders, (18%) had postoperative complications that led to another revision surgery (removal of a component), including a loose glenoid component (four shoulders), dislocations (two shoulders) and a periprosthetic joint infection (one shoulder).The average time to revision surgery was 13 months (range 2-35 months).Three patients who underwent revision for glenoid loosening had conversion to hemiarthroplasty, while the other patient had revision to another reverse shoulder arthroplasty since the patient had enough remaining bone stock to receive a new baseplate.There were four patients with postoperative glenoid loosening that required additional revision surgeries at an average of 1.12 years postoperatively.Scapular notching was also noted in three shoulders.Due to insufficient information within the article specifying which implants had which adverse reactions, only one implant will be reported within the complaint.The article also mentions humeral lucency and glenoid lucency, however does not report if progressive, or state any interventions--it is based on radiographs.

Manufacturer 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) used to capture medical device removal.

• Brand Name: UNKNOWN SHOULDER GLENOSPHERE
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9429392
• MDR Text Key: 185495833
• Report Number: 1818910-2019-118765
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2020
• 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