MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 24MM KATALYST RADIAL HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number 221424

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 01/13/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, patient underwent a primary left catalyst bipolar radial system on (b)(6) 2022 due to fracture.He was in pain in the elbow and began having pain in the wrist.He was found to have a filed radial head arthroplasty with loose hardware.He also was found to have shortened of the radius relative the ulna.This adverse event was addressed by revision surgery on (b)(6 2023, in which the 24mm catalyst radial head and 7.5mm catalyst stem were explanted.Found to be significant arthritis of the capitellum.There was significant amount of metallosis within the synovium of the joint.X-rays of the radiocapitellar joint demonstrated good alignment of the implant with no overstuffing.X-rays of the wrist demonstrated improvement of the ulnar variance although there is still some residual ulnar positivity.The elbow was taken through range of motion and found to be stable.The patient was awakened from anesthesia and the tourniquet was deflated.Brought back to the postoperative care unit in stable condition.

Manufacturer Narrative

Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that x-rays ((b)(6) 2023) showed that the revised head had disassociated from the stem.The root cause of the reported radial head disassociation is likely multifactorial given the patient¿s chronic essex-lopresti injury with persistent ulnar positivity, ulnocarpal abutment syndrome and distal radioulnar joint instability, as these are known sources of pain, clicking (popping), limited range of motion and tissue degeneration.The surgeon documentation indicated discussions with the patient regarding potential staged future interventions to address the ulnar variance/ulnocarpal abutment but noted that the patient possibly will not return to baseline.The patient impact included the reported symptoms, component disassociation and subsequent revision.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for katalyst¿ bipolar radial head system revealed that as with all internal fracture fixation devices, potential adverse effects include loosening or change in position of the implant or its components.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.B7: other relevant history, including preexisting medical conditions (e.G.,allergies,race,pregnancy,smoking and alcohol use, hepatic/renal dysfunction, etc.) h6: health effect - clinical code and medical device problem code.

• Brand Name: 24MM KATALYST RADIAL HEAD
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18735602
• MDR Text Key: 335698778
• Report Number: 1020279-2024-00396
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00885556827321
• UDI-Public: 00885556827321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221424
• Device Lot Number: KV1039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 7.5MM CATALYST STEM, LOT#:KV0154.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male