MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STEM / SHAFT ASSY - 7.5MM; KATALYST BIPOLAR RADIAL HEAD SYSTEM

Catalog Number 221675

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 12/07/2016

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

Report 1 of 2; other mfg report #: 3004608878-2017-00012.It was reported that the radial head components disassociated while the patient was splinted within two weeks of implantation.Once removed during a revision surgery, the surgeon reattached the head and the stem and was able to pull the two pieces apart with her hands.

Manufacturer Narrative

Integra has completed their internal investigation on february 23, 2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; there are four primary failure modes that could result in detachment of a katalyst implant following implantation; defects in the manufacturing of the radial head / poly assembly or the radial head stem assembly; improper surgical technique; damage to the implant during the assembly process; and, post-operative damage to the implant due to the patient¿s medical condition or blunt force trauma.Dhr review; the 7.5 mm radial head stem assemblies (lot # kv0103, (b)(4) pieces) were sent to ils (b)(4) for packaging and gamma sterilization, returned to ils (b)(4) on august 5, 2015, inspected and released into finished goods inventory on august 13, 2015.There were no mrrs or variances associated with the inspected final packaged implants.Complaints history; including these complaints, there have been a total of four reported complaints regarding the post-operative detachment of the radial head/poly assembly and the radial head stem assembly in the past 24 months.The four complaints are associated with two separate surgeries, resulting in a complaint rate of 0.501% based on the calculated number of 399 completed surgeries.Conclusion: the probable root cause for these complaints is noncompliance from the patient to follow post-operative care.It isn¿t clear if the patient¿s medical condition also contributed to a failed prosthesis.

• Brand Name: STEM / SHAFT ASSY - 7.5MM
• Type of Device: KATALYST BIPOLAR RADIAL HEAD SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6260794
• MDR Text Key: 65099199
• Report Number: 3004608878-2017-00011
• 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: company representative
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 221675
• Device Lot Number: KV0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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
• Treatment: 221424 -RADIAL HEAD - 24MM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR