MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND HIGHMO PE CUP D42 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Catalog Number 130742003

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/19/2020

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

Delta xtend reverse shoulder replacement unstable.If other, describe --> revision reverse shoulder arthroplasty, patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> dislocation, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> yes, if yes, describe --> x-rays, ct scan, is the patient part of a clinical study --> no, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

Event Description

Added additional patient code joint disorder to capture impingement and coded (b)(4) with implant bearing wear - polyethylene.

• Brand Name: DXTEND HIGHMO PE CUP D42 +3MM
• 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: 10115548
• MDR Text Key: 193930563
• Report Number: 1818910-2020-13026
• Device Sequence Number: 1
• Product Code: KWS
• 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,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130742003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM; DXTEND HIGHMO PE CUP D42 +3MM
• Patient Outcome(s): Required Intervention