MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW NO LOCK D4.5X18MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130770018

Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/08/2020

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

Patient was revised due to loosening of the glenosphere at the bone to implant interface.Patient had an accident in nursing home in 2018 that contributed to loosening of the glenosphere.The loose hardware was removed.The cemented delta stem was well fixed.Surgeon implanted cta head on stem.Doi: (b)(6) 2011, dor: (b)(6) 2020 left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The metaglene was completely loose and dislodged from the glenoid and the glenosphere was detached from the metaglene.

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.H10 additional narrative: corrected: h6 (device code).

• Brand Name: DXTEND SCREW NO LOCK D4.5X18MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10311226
• MDR Text Key: 199983402
• Report Number: 1818910-2020-16611
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027782
• UDI-Public: 10603295027782
• 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,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130770018
• Device Catalogue Number: 130770018
• Device Lot Number: 5056467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEMENTED DELTA STEM; DXTEND GLENOSPHERE ECC D42MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D42 +3MM
• Patient Outcome(s): Required Intervention