MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MBLOC HUM EPI 1 D10 STD; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEMS

Model Number 130710100

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 06/20/2014

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

On (b)(6) 2009; patient underwent revision of right hemiarthroplasty to a reverse total shoulder arthroplasty using a delta xtend prosthesis, depuy.On (b)(6) 2014; at five-year follow-up, patient continues to have some pain in her right shoulder.X-rays revealed zone one loosening in the humerus.Patient has had no revision thus far and is to follow-up again in two years.Pmh: depression, fibromyalgia, gastric reflux, gout/pseudo-gout, hypertension, high cholesterol, migraines, osteoarthritis, osteopenia, anxiety and thyroid disease.Doi: (b)(6) 2009 (revision to delta xtend), doe: (b)(6) 2014.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary:no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

• Brand Name: DXTEND MBLOC HUM EPI 1 D10 STD
• Type of Device: DELTA XTEND 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: 9738496
• MDR Text Key: 214812939
• Report Number: 1818910-2020-05577
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027133
• UDI-Public: 10603295027133
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 130710100
• Device Catalogue Number: 130710100
• Device Lot Number: AS400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 68