MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 XTND GLENO D42MM +2MM; SHOULDER GLENOSPHERE

Model Number 1307-62-142

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 08/07/2020

Event Type  malfunction  

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

It was reported that the glenosphere would not mate with the metaglene.This was tried multiple times and the internal screw in piece would not engage with the metaglene.No fault of the surgeon.There was a surgical delay of 30 mins.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not 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.

• Brand Name: XTND GLENO D42MM +2MM
• Type of Device: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10434223
• MDR Text Key: 203817310
• Report Number: 1818910-2020-18490
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295502500
• UDI-Public: 10603295502500
• Combination Product (y/n): N
• PMA/PMN Number: K183077
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1307-62-142
• Device Catalogue Number: 130762142
• Device Lot Number: D19051764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHOULDER METAGLENE