MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER GLENOID; UNK SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID

Device Problem Migration (4003)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2017

Event Type  malfunction  

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, "sequential 3-dimensional computed tomography analysis of implant position following total shoulder arthroplasty" written by eric t.Ricchetti, md, bong-jae jun, phd, richard a.Cain, md, ari youderian, md, eric j.Rodriguez, bs, david kusin, md, naveen subhas, md, thomas e.Patterson, phd, and joseph p.Iannotti, md, phd published by journal of shoulder and elbow surgery 2017 was reviewed.The article's purpose was to evaluate glenoid component position over time using sequential 3d ct imaging analysis with minimum 2 year follow up to better define preoperative and postoperative anatomic and implant factors that contribute to glenoid component shift over time.Data was compiled from 20 patients age range 53-86 years all who received depuy glenoid implants.Cement manufacturer is not identified.The article only discusses the glenoid component and not other shoulder components.Figures 1-6 provide ct and radiographic imaging for illustrative purposes with some images with narrative description of detection of osteolysis.Depuy products: anchor peg all poly glenoid, steptech anchor all poly glenoid.Adverse events: radiographically detected osteolysis with and without component "shift" (ct scans were taken in series count of 3 and those with shift were noted to be at risk for loosening; no interventions provided).One failure case (treated with revision and intraoperative findings of full thickness tear of supraspinatus tendon).

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 : the device associated with this report was not 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.

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: UNK SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9996980
• MDR Text Key: 194080974
• Report Number: 1818910-2020-11303
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention