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

Catalog Number 130738203

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Revision delta xtend due to dislocation of the glenohumeral components: primary surgery was carried out in 2012.X-rays indicated that there is scapula notching and inferior screw could be palpated by the surgeon.Surgeon indicated that could be the reason for the dislocation.Revision surgery was carried out on (b)(6) 2019.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).A complaint was received regarding a delta xtend shoulder construct stating: "revision delta xtend due to dislocation of the glenohumeral components: (b)(6) 2019.Primary surgery was carried out in 2012.X-rays indicated that there is scapula notching and inferior screw could be palpated by the surgeon.Surgeon indicated that could be the reason for the dislocation.Revision surgery was carried out on (b)(6) 2019." additional information requests found: the cup, glenosphere and screw lock were revised.The surgeon did indicate that he believed the notching was due to cup impingement.The explanted cup indicated that it was in contact with the inferior screw there was no allegation of fault against our products.The inferior screw was not malpositioned.X-rays unavailable.Note: there are no allegations against the stem, which has also not been indicated as a revised component.No device associated with this report will be received for examination, as these were discarded by the hospital.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found one additional related reports against the provided product code/lot code combination for the glenosphere (130760038/5124520), but this was for an unrelated failure: surgical intervention due to excessive osteophyte buildup.Two additional complaints were found against the cup (130738203/52247084), but these were also for unrelated failures: 1 infection and 1 fit issue intra-op.No additional reports were found against the screws.Based on the inability to find any additional related reports against the provided product code/lot code combinations it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.A dhr review was conducted on the two products that were dislocating, 130760038 - lot 5124520 & 130738203 - lot 52247084.No anomalies were noted for either of the products.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a.Without the physical complaint samples associated with this report, it was not possible to determine if the devices failed to meet specifications at the time they were released for distribution.  the devices associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall, from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot = null.Device history batch = null.Device history review = null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 8447972
• MDR Text Key: 139696850
• Report Number: 1818910-2019-88312
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027362
• UDI-Public: 10603295027362
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130738203
• Device Lot Number: 52247084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention