MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MOD EPI 1 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130720103

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

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

It was reported that while trying to assemble the epiphysis to the 10 unite stem it was noted the two components would not slide together on the epiphysis post.Unsure of which component may be the issue.Surgeon felt the issue was the epiphysis.Another one was opened and the two components were assembled with no problems.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, 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.

• Brand Name: DXTEND MOD EPI 1 ECC RIGHT HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12452589
• MDR Text Key: 270782402
• Report Number: 1818910-2021-19821
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295027300
• UDI-Public: 10603295027300
• Combination Product (y/n): N
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130720103
• Device Catalogue Number: 130720103
• Device Lot Number: 9709729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLOBAL UNITE STD STEM SZ 10