MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW LOCK D4.5X24MM; DELTA XTEND IMPLANTS : SCREWS

Catalog Number 130790024

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Patient was revised to address loosening of the metaglene component at the bone to implant interface.Glenosphere, metaglene, humeral cup and 3 screws were explanted.Converted to a cta head.Doi: (b)(6) 2017, dor: (b)(6) 2019, left shoulder.

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.Product complaint # (b)(4).Investigation summary: no device associated with this report was 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.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 SCREW LOCK D4.5X24MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8463635
• MDR Text Key: 140275350
• Report Number: 1818910-2019-88895
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027836
• UDI-Public: 10603295027836
• Combination Product (y/n): N
• PMA/PMN Number: K120174
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130790024
• Device Lot Number: 5269976
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention