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

Catalog Number 221424

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

1 of 2 reports: other mfg report number: 1651501-2018-00055.It was reported that product was implanted on (b)(6) 2017, and on (b)(6) 2017 the follow-up radiology was fine.On (b)(6) 2017 the patient complained about clicking, pain and limited range of motion and a revision surgery was required to remove the product on (b)(6) 2018.

Manufacturer Narrative

At this time, the device has not been returned to integra for evaluation or any additional information has been provided.We have requested additional information and clarification regarding the usage of the term "discharged" with no response received at this time.Integra is unable to confirm the reported non-conformance or determine root cause.The most probable root cause was most likely loosening or dissociation possibly from surgical technique, patient after care compliance, or patient anatomy.

Manufacturer Narrative

Additional information received: patient: young male.Lot number: kv0117.Explanted on (b)(6) 2018.Patient outcome: "head fracture radius mason 3, without collateral damage.There was no pollution.There was no interruption in immediate movement after surgery".Additional comments from distributor : "the physician did not report on any problem about snapping together intraoperatively of the implant, the opposite is true ¿ he reported that operation was properly performed ¿.The stem and the head were properly snapped together.One month after the patient has returned with complaints about clicking sounds, pain and limited rom.Following these complaints the implant was removed and found to be discharged inside patient's body.".

Manufacturer Narrative

Dhr - a review of the lot records was conducted, and did not discover any indications of problems that could have caused or contributed to the complaint.The 221424 radial head was returned to integra in an assembled condition, so the failure could not be confirmed from its immediate appearance.However, the failure was confirmed from the follow-up x-ray.An analysis was performed by product development engineering.Visual inspection of the returned device under light microscopy indicated no obvious device malfunction.Per engineering, the articulating motion of the head on the stem felt relatively smooth in pitch, roll, and yaw, with a brief resistance on initial motion (static vs.Dynamic friction).The surgeon¿s experience with radial head surgery and the catalyst system likely rule out a surgical technique-related complication.Possible heterotopic ossification may explain some patient symptoms, but a definitive conclusion regarding the discharge of the radial head could not be reached.

Manufacturer Narrative

Additional information received: the same surgeon removed both katalysts.Did the surgeon implant one or both? if so, what is the experience level of the surgeon with our system or the surgery in general? answer from distributor: this is the same surgeon who performed both cases.He is a senior physician & an expert in the field of hand surgery, performing more than 150 radial head replacements of which about 30 cases with "katalyst" system.Did the surgeon need to change heads intra-operatively or otherwise re-seat the head during surgery? answer from distributor: the course of the operation was perfectly normal without any complications.The problem arose when the patient arrived for an analysis follow-up / post-op.The surgeon indicated that the head was easily removed, but the implant was received in the assembled state.Can we confirm that the surgeon re-assembled the implant, and if so, how many times? answer from distributor: you can we confirm that the surgeon re-assembled the implant.In addition, we also tried a few times to connect & disconnect the components, in order to understand the source of the fault did the patient indicate when the clicking sounds would occur? was there a specific motion or motions that resulted in the clicking sound? answer from distributor: the clicking sounds would occur each time there was movement involved, there was no specific motion.Did the patient experience any traumatic events (e.G.Falling, hitting elbow, etc.) after implantation and the follow-up visit? answer from distributor: the patient didn't experience any traumatic event after implantation and the follow-up visit.

• Brand Name: RADIAL HEAD - 24MM
• Type of Device: KATALYST BIPOLAR RADIAL HEAD SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7819895
• MDR Text Key: 118386062
• Report Number: 1651501-2018-00054
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 221424
• Device Lot Number: KV0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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