MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS LINER STANDARD 0; TITAN SHOULDER SYSTEM

Catalog Number ¿LNR-0960-00S¿

Device Problem Unintended System Motion (1430)

Patient Problem Failure of Implant (1924)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Other mfg report numbers: same failure.Different patients.1651501-2021-00007, 1651501-2021-00008, 1651501-2021-00009.A facility reported that months after surgery, the glenosphere have been disassembled from glenoid baseplate and revision surgery was required.

Manufacturer Narrative

Complaint sample was not received for evaluation; however, photographs were provided.The liner is shown with the corresponding glenosphere.The liner appears to be significantly damaged, featuring gouges, cracks, and deformities on nearly all surfaces.It is expected that the damage was inflicted during the explantation surgery and/or during handling after explantation.This assumption is further supported by the x-ray images provided by the customer which do not show any damage to the liner prior to explantation.As no failure is alleged against the liner and the damage to the liner appears to have resulted after the alleged failure, this investigation could not confirm any failure for the liner.The most probable cause for early dissociation of the rss glenosphere from the baseplate is improper surgical technique due to technical errors such as low impaction force, fluid contamination of the taper, or impingement between the underside of the glenosphere and the glenoid.If the part is later returned to integra this investigation may be reopened and updated.

Event Description

N/a.

• Brand Name: LINER STANDARD 0
• Type of Device: TITAN SHOULDER SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 11708518
• MDR Text Key: 246755139
• Report Number: 1651501-2021-00010
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K130050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: ¿LNR-0960-00S¿
• Device Lot Number: QJ1269
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BASE PLATE GBP-0960-030-15 LOT 185823G; BASE PLATE GBP-0960-030-15 LOT 185823G