MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA RADIAL HEAD - 24MM; KATALYST BIPOLAR RADIAL HEAD SYSTEM

Catalog Number 221424

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/22/2014

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

Other mfg report # 3004608878-2016-00035.This report is about a (b)(6) male that on (b)(6) 2014 underwent a right elbow prosthesis implantation.Shortly after that, he started experiencing pain and limited mobility around his elbow, necessitating a revision surgery.Subsequent x-rays conducted on (b)(6) 2014 confirmed an ununited fracture, proximal third of right ulna, with the posterior compression plate fractured through its middle third and with lateral displacement of the ununited distal ulnar fragment.Prior total arthroplasty, radiohumeral joint, with lateral subluxation of the distal radial component.Additional information has been requested.

Manufacturer Narrative

Summary of the legal document received on june 13, 2016: on (b)(6) 2014 a (b)(6) male had an accident while riding his skateboard.He was taken to emergency room and x-rays confirmed a diagnosis of a complex comminuted fracture dislocation of the proximal forearm with a comminuted fracture of the proximal ulnar diaphysis with apex dorsal angulation and dislocation of the radial head with impaction fracture.On (b)(6) 2014, was performed a radial head replacement as well as an open reduction and internal fixation of the ulna using cancellous bone chips and dbx bone graft.Following surgery and occupational therapy, the patient was discharged with instructions on at-home splint management.On (b)(6) 2014 on his post-surgery follow-up, the splint was removed and he was found to be in improved and stable condition in regards to his elbow.On (b)(6) 2014, three months after the implantation, the patient was getting out of his bed in the morning, supporting himself with both arms, when he felt his right elbow give, and immediately experienced pain, swelling, and limited mobility.An x-ray confirmed a subluxation of the distal radial component 10mm laterally.This subluxation forced great stress on the olecranon plate implanted on the ulna, causing it to fracture.The patient plans to have the revision surgery done at the end of summer 2016.

Manufacturer Narrative

Integra has completed their internal investigation on july 20, 2016.The investigation included: methods: radiographs evaluation, review of device history records, review of complaints history.Results: based on the examination of the radiographs provided, integra is able to confirm the reported non-conformance.The 24 mm katalyst radial head/ poly assembly (p/n 22-1424) detached from the 6.5 mm radial head stem assembly (p/n 22-1665).The device associated with this complaint was not returned for evaluation and therefore we are unable to determine if the radial head / poly assembly detached from the radial head stem assembly due to mechanical failure, surgical technique, the patient¿s physical condition or a combination of factors.Since no one at ils (b)(4) is clinically qualified to interpret radiographs, no further conclusions regarding the cause of the alleged device failures and non-fusion of the ulna can be made.Dhr review; the lot numbers of the two portions of the final implant (p/n 221424 and p/n 221665) were not provided.Complaints history; a query found six additional complaints associated with the reported failure of an implanted katalyst radial head/poly assembly.The query was based on searching for ¿katalyst¿ and the three radial head/poly assembly implant part numbers, 221418, 221421 and 221424.The query was limited to the time frame of january 1, 2010 ¿ december 31, 2015.The trend analysis failure rate was performed by determining the number of reported non-conformances for the particular implant.A failure rate percentage was determined by calculating the non-conformance rate as a function of the number of opportunities.A review of domestic and international sales information determined that approximately (b)(4) katalyst radial head/poly assemblies (p/n 22-14xx) were sold during the time frame of january 2010 ¿ december 31, 2015.Including this complaint, the seven reported complaints represent a failure rate of (b)(4).Conclusion: the device associated with this complaint was not returned for evaluation and therefore integra is unable to determine if the radial head / poly assembly detached from the radial head stem assembly due to mechanical failure, surgical technique, the patient¿s physical condition or a combination of factors.Since no one at ils (b)(4) is clinically qualified to interpret radiographs, no further conclusions regarding the cause of the alleged device failures and non-fusion of the ulna can be made.

• Brand Name: RADIAL HEAD - 24MM
• 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: 5463159
• MDR Text Key: 39120196
• Report Number: 3004608878-2016-00034
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 221424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 13_5 X 16MM NON-LOCK HEX SCREW-NOT INTEGRA DEVICE
• Patient Outcome(s): Other
• Patient Age: 42 YR