MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND GLENOSPHERE ECC D38MM; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number	130760038
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that this was an rsa performed on (b)(6) 2021.The glenosphere was not able to be deployed appropriately.The procedure was completed with a replacement less than 30-minute surgical delay.There was no harm to the patient.The device was brand new and the first use when the issue occurred.It was not fully described how inappropriate the deployment was.The patient is expected to take medical follow-up.
Additional 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 review of the device manufacturing records (dhr) was performed as part of this investigation.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 GLENOSPHERE ECC D38MM
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12195596
• Report Number: 1818910-2021-15494
• Device Sequence Number: 19783832
• Product Code: PHX
• UDI-Device Identifier: 10603295027744
• UDI-Public: 10603295027744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 130760038
• Device Catalogue Number: 130760038
• Device Lot Number: 5366090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1