MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS RADIAL HEAD - 24MM; KATALYST BIPOLAR RADIA HEAD SYSTEM

Catalog Number 221424

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2018

Event Type  Injury  

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

It was reported that a male patient in the age range between 25 to 35 years old with mental disorder had a broken implant after a suicide attempt.The patient arrived to the hospital with several fractures, and after x-rays examination, the implant was found to be broken and a surgery was performed to explant the unit.Chronology: on (b)(6) 2018 a radial head exchange surgery was performed with the implant.On (b)(6) 2018 during routine check, the implant head was found to be "discharged".On (b)(6) 2018 additional surgery was performed in order to remove the unit and place a new implant.No injury to patient reported and his condition is good.

Manufacturer Narrative

The manufacturing records for lot number 221675 was reviewed.A quantity of 2 devices were inspected on 06/05/2015.No abnormalities or nonconformances were identified that would have caused or contributed to the event.The implant was assessed by engineering and no out of tolerance conditions, defects, abnormalities or damage could be identified.The most likely failure mode here was loosening, rather than implant breakage, seeing as there is no evidence of breakage on the returned parts.Based on the assessment performed on the returned device , integra is unable to confirm the reported non-conformance or determine root cause.Base upon the assessment of the returned the device, the root cause was most likely loosing or dissociation possibly from surgical technique, patient after care compliance, or patient anatomy.

• Brand Name: RADIAL HEAD - 24MM
• Type of Device: KATALYST BIPOLAR RADIA HEAD SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 11101 metric boulevard; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 11101 metric boulevard; austin TX 78758
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7685142
• MDR Text Key: 113890952
• Report Number: 1651501-2018-00048
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K032806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 221424
• Device Lot Number: 22-1675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other