MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTND GLENO D42MM +2MM; SHOULDER IMPLANT

Model Number 1307-62-142

Device Problems Difficult to Insert (1316); Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

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

Surgeon was performing a reverse shoulder arthroplasty.He had finished preparing the gleniod, opened and implanted the metaglene and secured it with 2 locking screws.After this he requested a 42+2 standard glenosphere implant, he opened and inserted the implant onto the metaglene as per surgical guide.It was at this point that he had an issue engaging the threads on the post, at the back of the glenosphere into the center of the metaglene.The post on the glenosphere did center into the metaglene but the threads to tighten and secure the implant did not engage.The surgeon then used a mallet to try get the threads to engage but this was not successful.He then tried to remove the glenosphere but could not as it had secured itself but not correctly using the threads on the post.All implants remained in patient as nothing could be done after he had used a mallet to implant the glenosphere.Surgery was successfully completed after a 20 minute surgical delay.

Event Description

Additional information received indicated that there was no known consequences to the patient.

Manufacturer Narrative

Product complaint #
=
> (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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: XTND GLENO D42MM +2MM
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12181565
• MDR Text Key: 261980823
• Report Number: 1818910-2021-15388
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295502500
• UDI-Public: 10603295502500
• Combination Product (y/n): N
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1307-62-142
• Device Catalogue Number: 130762142
• Device Lot Number: D19120133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND METAGLENE; XTND GLENO D42MM +2MM; DXTEND METAGLENE; XTND GLENO D42MM +2MM