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

Catalog Number UNK SHOULDER GLENOID

Device Problems Fracture (1260); Naturally Worn (2988)

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

Event Date 01/01/2015

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.

Event Description

The literature article entitled ¿analysis of severely fractured glenoid components: clinical consequences of biomechanics, design, and materials selection on implant performance¿ by farzana ansari, phd; taylor lee, louis malito, ms; audrey martin, bs; stephen b.Gunter, md; samuel harmsen, md; tom r.Norris, md; mike ries, md; douglas van citters, phd; and lisa pruitt, phd; published in the journal of shoulder and elbow surgery, in 2015 was reviewed.The article was based on 16 retrieved glenoids with severe fracture were analyzed after explant.All implants were catastrophic failures.The glenoids span the evolution of tsr design and material variables during the past 20 years.The authors contend that modern hxl glenoid components are still at risk of catastrophic fracture in vivo in currently available tsrs.Out of the 16 implants, ten were from depuy and all were pegs.All glenoids were made of hylamer but one, which was cross linked.The article contains a table that breaks down each implant, patient age and sex, time in vivo, radial mismatch and minimum thickness.The cases are listed below: case #6) (b)(6) y/o male, 19.6 years, 3-mm radial mismatch, 2.52 minimum thickness.

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, however, photographs of the subject complaint sample were provided for review confirming the reported event.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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Patient code 3189, used to capture medical device removal.

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9383926
• MDR Text Key: 185209360
• Report Number: 1818910-2019-116812
• 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,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR