MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK TIBIAL BASE SZ 4 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71421304

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tkr was performed on (b)(6) 2019, the patient presented in the last months of the year 2021 and early 2022 a progressive mobilization of the implant, accompanied by pain and mainly tibial osteolysis.Therefore on (b)(6) 2022 the patient was subjected to further surgery revision and total replanting of the prosthetic implant, associated with massive bone graft in the proximal tibial area (duration of surgery 4 hours and 39 minutes).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 23 months post implantation due to progressive mobilization of the implant, pain and ¿mainly tibial osteolysis¿ which required ¿massive bone graft in the proximal tibial¿ area with a surgical duration of 4 hours and 39 minutes.Reported onset of signs and symptoms appears to be between 6 to 12 months prior to revision.It was communicated that the requested clinical/medical documentation was not available.Without the requested documentation, contributing clinical factors cannot be definitively concluded.The patient impact included the reported progressive mobilization over an approximate 6-12 month duration, pain, osteolysis with subsequent early revision and massive bone grafting, and a significant 4hr and 39 minute surgical time.Although lengthy surgical times increase the risks of infection, no further adverse events have been reported.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the instructions for use documents for knee systems revealed that with all joint replacements, asymptomatic, localized, progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to particulate wear debris.Osteolysis can lead to future complications necessitating the removal and replacement of prosthetic components.Migration of the components is also listed as a possible adverse effect.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 this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, alignment, size selected, patient anatomy, traumatic injury, patient medical history and/or bone quality.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.Internal complaint reference number: (b)(4).

• Brand Name: LEGION HK TIBIAL BASE SZ 4 LT
• 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: 15721523
• MDR Text Key: 303027801
• Report Number: 1020279-2022-04671
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00885556109144
• UDI-Public: 00885556109144
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K081111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71421304
• Device Catalogue Number: 71421304
• Device Lot Number: 17BBP0013A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR