MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND GLENOSPHERE STD D42MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number 130760142

Device Problem Difficult to Insert (1316)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (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

This case was very complicated, a very bleeding patient with very difficult exposure, in addition to being our first shoulder prosthesis (both mine and elen's).02 ¿glenosphere¿ implants were opened, not by mistake, but due to a possible defect.The first one to be opened, the choice of the doctor was number 42.But it turned in false, not adapting to the metaglena implant.The doctor spent 34 minutes trying to implant the same.Surgeon reported that this had never happened, and that he found it very strange that the implant was spinning in false.After several attempts, we found that the thread pitch was flawed, not at the ends, but at the half of the ¿thread¿.The surgeon then requested the size 38 glenosphere, and it fit perfectly without any effort, rotating normally and fixing on the first attempt.The incident was reported to the representative débora at the end of the surgery, and the implant in question was separate to be collected.

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.Removed not applicable (3189) code and replaced with no code available (3191) to capture prolonged surgery and insufficient information.

• Brand Name: DXTEND GLENOSPHERE STD D42MM
• Type of Device: DELTA XTEND IMPLANTS : 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: 10367469
• MDR Text Key: 202360385
• Report Number: 1818910-2020-17598
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027775
• UDI-Public: 10603295027775
• 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
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760142
• Device Catalogue Number: 130760142
• Device Lot Number: 5340940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM