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

Model Number 1307-62-042

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 10/09/2020

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 neither of the glenospheres would thread into the metaglene.The threads appeared to get damaged somehow.The surgeon felt like something may have been wrong with the metaglene.But the third one we tried finally threaded in.A surgical delay of 10 minutes.Doe: (b)(6) 2020 left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: XTND GLENO ECC 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: 10720733
• MDR Text Key: 212562442
• Report Number: 1818910-2020-23111
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295502449
• UDI-Public: 10603295502449
• 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: 10/09/2020

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: 1307-62-042
• Device Catalogue Number: 130762042
• Device Lot Number: D19081512
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHOULDER METAGLENE; XTNDGLENO ECCD42MM+0MM SHRTPST; UNKNOWN SHOULDER METAGLENE; XTNDGLENO ECCD42MM+0MM SHRTPST
• Patient Age: 71 YR
• Patient Weight: 88