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).Attachment file size is too large to include with initial submission.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 #8) (b)(6) male, 17.2 years, 3-mm radial mismatch, 1.35 minimum thickness.

Manufacturer Narrative

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

Manufacturer Narrative

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.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: SHOULDER GLENOID
• 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, PA 19380-0988 ; 6107428552
• MDR Report Key: 9383992
• MDR Text Key: 184334456
• Report Number: 1818910-2019-116820
• 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: 11/04/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2019
• 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
• Patient Age: 58 YR