MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER IMPLANT

Catalog Number UNK SHOULDER IMPLANT

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 06/01/2019

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 ¿early failure of an inlay modular shoulder arthroplasty for proximal humeral fracture in a retrospective series¿ written by richard s.Page et al; printed in the journal orthopedics and rheumatology volume 6, issue 1, printed in june 2019, was reviewed.The aim of the study was to review the failure rate and modes of an inlay modular humeral hemiarthroplasty prosthesis used for proximal humeral fractures.The authors present their experience with global unite fracture after noting a high early rate of failure via superior migration.They postulated the modular convertible bodies may increase the humeral height in comparison to the non-convertible hemiarthroplasty due to the component geometry, leading to early rotator cuff failure.A saw bone model was used to assess the differences in height and offset.The depuy products used: the global unite.Under retrospective review, a saw bone comparison of the height and offset of the global fx and the convertible, platform based global unite.Six patients had a global unite hemiarthroplasty between 2013 and 2015.A 66% rate of failure was found with these six cases within this series via a mechanism of superior migration.The individual results per patient are broken down by case.This complaint will capture case six: (b)(6)-year-old female; twelve months until failure; superior migration.

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.H10 additional narrative: corrected: h6.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER IMPLANT
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9554933
• MDR Text Key: 173895762
• Report Number: 1818910-2020-00683
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention