MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +3MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL CUP

Model Number 130738203

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 06/08/2020

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

Revision of delta xtend due to notching.Removal of glenosphere and liner.Lateralised (+4) glenosphere implanted with new liner.Was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? revision surgery, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4) device property of: none, device in possession of: none, (b)(4) device property of: none, device in possession of : none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

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.

• Brand Name: DXTEND STAND PE CUP D38 +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: 10176061
• MDR Text Key: 195909505
• Report Number: 1818910-2020-14177
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027362
• UDI-Public: 10603295027362
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130738203
• Device Catalogue Number: 130738203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D38MM; DXTEND STAND PE CUP D38 +3MM; DXTEND GLENOSPHERE STD D38MM; DXTEND STAND PE CUP D38 +3MM
• Patient Outcome(s): Required Intervention