MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND METAGLENE; SHOULDER METAGLENE

Catalog Number 130760000

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 01/01/2019

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.

Event Description

Revision of standard glenosphere sz.42 right side because of fracture of glenosphere´s screw and disassociation of the glenosphere and metaglene.Doi: 2017, dor: (b)(6) 2019.No surgery delay reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Product complaint #: (b)(4).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.Event problem and evaluation code: pe code and patient harm.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: added: d4, d10 and h4.Corrected: d1, d2, d3, h3 and 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.Addendum added (b)(6)2020.Following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be closed with an undetermined conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.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 will be filed as appropriate.

• Brand Name: DXTEND METAGLENE
• Type of Device: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 9375865
• MDR Text Key: 168028132
• Report Number: 1818910-2019-118025
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 130760000
• Device Lot Number: 5278292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR