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

Model Number 130760000

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/17/2020

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 peri prosthetic fracture and loosening of the metaglene at the bone to implant interface.No surgical delay.Doi: unknown, dor: (b)(6) 2020, affected side: unknown.

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 METAGLENE
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10329975
• MDR Text Key: 200590956
• Report Number: 1818910-2020-16939
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027737
• UDI-Public: 10603295027737
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130760000
• Device Catalogue Number: 130760000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND METAGLENE; UNKNOWN SHOULDER GLENOSPHERE; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW
• Patient Outcome(s): Required Intervention