MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK 11MM BOLT - SLEEVE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71421385

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 01/13/2021

Event Type  Injury  

Event Description

It was reported that, after surgery, a revision surgery was performed to explant a broken legion hk 11mm bolt - sleeve.The patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed to explant a broken legion hk 11mm bolt - sleeve.The patient outcome is unknown.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As batch information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.The failure mode included in the risk management documentation is within expected occurrence rates.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.We will continue to trend through our post market surveillance process.A clinical evaluation noted that the implantation date is unknown and no relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.Some potential causes of the reported event could include but are not limited to traumatic injury, overuse or user/procedural variance.No further investigation is warranted for this complaint at this time.However we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

Event Description

It was reported that after primary tkr, the patient presented a prosthetic joint infection, and underwent revision surgery to perform a washout and a poly exchange.The legion hk 11mm bolt was explanted the device had broken off, causing the sleeve to rotate.The patient is currently mobilizing adequately asymptomatic.Additional details have not been provided at this time.

Manufacturer Narrative

B5: describe event or problem h6: health effect-clinical code and health effect-impact code.H10: internal complaint reference: (b)(4).Section h3, h6: the associated device was returned and evaluated.The lab analysis concluded that the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The insert, bolt, and sleeve were retrieved.Damage is present in the middle hole of the insert and on the articulating surface of the insert.The bolt and sleeve did not show any damage.There were no observations of material or manufacturing deviations in the course of this investigation.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that this case reports that a revision was performed to explant a broken legion hinge bolt sleeve.The implantation date is unknown, and without responses to the documentation/information requests, the clinical root cause of the reported event cannot be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LEGION HK 11MM BOLT - SLEEVE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/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: 11276759
• MDR Text Key: 230210893
• Report Number: 1020279-2021-00926
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556029213
• UDI-Public: 00885556029213
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 71421385
• Device Catalogue Number: 71421385
• Device Lot Number: 13FTM0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention