MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +6MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738206

Device Problem Naturally Worn (2988)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 10/22/2020

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

The patient was revised to address loosening of the metaglene at the bone to implant interface.It was also reported that screws are broken and humeral poly was worn.There was also osteolysis.Base plate/screws gleosphere implant information not available.Doi: 2005, dor: (b)(6) 2020, right shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: DXTEND STAND PE CUP D38 +6MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10792530
• MDR Text Key: 214789797
• Report Number: 1818910-2020-24018
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027379
• UDI-Public: 10603295027379
• Combination Product (y/n): N
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130738206
• Device Catalogue Number: 130738206
• Device Lot Number: 2728198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND STAND PE CUP D38 +6MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; DXTEND STAND PE CUP D38 +6MM; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR