MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND STAND PE CUP D38 +6MM; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Model Number	1100-12-100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	01/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Event or Problem Description
On (b)(6) 2014: patient underwent a right rtsa with a depuy implant, global unite and delta xtend secondary to a humerus fracture.Patient also had open reduction bone grafting and cleaning out of synovial pseudarthrosis performed.No intraoperative complications.Cement manufacturer not specified.On (b)(6) 2015: the patient was seen for the first time postoperatively.The surgeon¿s notes reveal that is due to the patient having a port placed for dialysis and some mental status changes.Upon physical examination, the humeral shaft nonunion is completely healed, however, the right humerus is determined to be dislocated medially; it does not move at all, the patient does not report pain and he is able to function within functional limits.No treatment indicated and follow-up again in three months.Pmh: rotator cuff tear, synovial pseudarthrosis, coronary bypass grafting.Doi: (b)(6) 2014 (rtsa).Doe: (b)(6) 2015 (follow-up).
Additional Manufacturer Narrative
Product complaint # : (b)(4).H6 patient code: no code available (3191) used to capture absence of treatment.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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).Investigation summary : no device associated with this report was received for examination.Visual examination of the provided images confirmed the reported event.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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 +6MM
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9732149
• Report Number: 1818910-2020-05426
• Device Sequence Number: 3320753
• Product Code: KWS
• UDI-Device Identifier: 10603295004127
• UDI-Public: 10603295004127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1100-12-100
• Device Catalogue Number: 130738206
• Device Lot Number: 5232520
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020; 03/23/2020; 03/30/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 02/20/2020; 03/24/2020; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 82