MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND MOD EPI 1 ECC LEFT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130720102

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/10/2020

Event Type  malfunction  

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

It was reported that a patient underwent an orthopedic procedure on (b)(6) 2020.Upon opening the implant, the internal sterile package was not fully sealed in a corner.Another like device was used to complete the procedure.There were no adverse events or patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device and packaging components associated with this report were not returned for examination.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.

• Brand Name: DXTEND MOD EPI 1 ECC LEFT HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10426783
• MDR Text Key: 203542850
• Report Number: 1818910-2020-18388
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027294
• UDI-Public: 10603295027294
• Combination Product (y/n): N
• PMA/PMN Number: K021478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130720102
• Device Catalogue Number: 130720102
• Device Lot Number: 5349037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR