MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS STEM / SHAFT ASSY - 7.5MM; KATALYST BIPOLAR RADIAL HEAD SYSTEM

Catalog Number 221675

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

A sales representative reported that on (b)(6) 2019 a katalyst bipolar radial head system (221675 - stem / shaft assy - 7.5mm) was used during a surgery.The surgeon implanted the radial head prothesis and closed the wound.He did range of motion tests and the prothesis head kept separating from the stem.He re-opened the incision and went on to exchange the prothesis with new construct.The surgeon advised that the ease of disassembly of the head/stem construct of the explanted prothesis is not normal.No patient injury reported and the event lead to 30 minutes surgical delay.1 of 2 reports.Other mfg report number: 1651501-2019-00006.

Manufacturer Narrative

Additional information received - the increase of surgery time didn¿t harm the patient; however, the anesthesia time and medication were increased.The patient was reported to be doing fine following implantation of other prothesis.Review of the dhr for 221675 stem / shaft assy - 7.5mm lot kv0121 showed no anomalies that may have contributed to the reported event.Based on the information to date, the root cause for the event is unknown.The product has not been returned to date; therefore, no failure analysis can be performed.

Manufacturer Narrative

Dhr showed no anomalies that may have contributed to the reported event.Based on the information to date, the root cause for the event is unknown.The product has not been returned to date; therefore, no failure analysis can be performed.

Manufacturer Narrative

The katalyst head and stem were returned to integra and underwent failure analysis.The head and stem were returned separated, and dimensional and visual inspection was performed.As received, there were no anomalies noticed on the katalyst stem.The device was dimensionally inspected, and all dimensions were within the specified tolerances.As received, there were no anomalies noticed on the katalyst head, with the exception of the poly insert.This piece contained come scratches that appear to be normal wear and tear from the implant/explant process.All measurements of the head/poly assembly measured within specification with the exception of the insert length (5.40+0.00, measured 5.86).Considering the poly material is expected to give to accommodate stem insert, and the assembly was constructed and deconstructed, this does not represent a failure.Based on the information to date, the root cause for the event is unknown.Failure analysis shows the device is within specification given the conditions of use.

• Brand Name: STEM / SHAFT ASSY - 7.5MM
• Type of Device: KATALYST BIPOLAR RADIAL HEAD SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 8354303
• MDR Text Key: 139843176
• Report Number: 1651501-2019-00005
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K032806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221675
• Device Lot Number: KV0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR