MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKN01000000

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthralgia (2355); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Type  Injury  

Event Description

It was reported that, after a right tka had been performed on (b)(6) 2022, during which an unknown s+n knee system had been implanted, the patient started experiencing pain of the knee on (b)(6) 2023.After a full examination of the knee, (x-rays, computed tomography, tests) it was found that the prosthesis had become loose.The patient had strictly followed the physician's post-operative instructions.The situation is currently unresolved and the patient has reported that it is very difficult for them to walk, an elbow crutch is being used to aid ambulation before a revision surgery is performed.

Manufacturer Narrative

Internal complaint number: (b)(4).

Manufacturer Narrative

The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided imaging appears to support the complaint with progressive radiolucency and worsening/malpositioned tibial component with subsidence medially with an apparent varus deformity as well as progressing radiolucency under the femoral component.Of note, there is no easily discernable cement mantle.Based on the information provided, the loosened components contributed to the patients reported pain and the progressive varus deformity of the right knee post total knee arthroplasty.The indiscernible cement mantle is suspect as a possible contributing factor to the noted radiolucencies and component loosening within 2 years of implantation.The patient impact includes the reported knee pain, component loosening, and varus deformity of the right knee requiring assist device for ambulation along with the need for revision/definitive treatment.Further patient impact cannot be determined.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 anthem¿ total knee system revealed that looseness of components can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.This has been identified as a possible adverse effect.A review of the risk management files 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 abnormal motion over time, bone degeneration, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.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.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 18389812
• MDR Text Key: 331295422
• Report Number: 1020279-2023-02578
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556531327
• UDI-Public: 00885556531327
• Combination Product (y/n): N
• Reporter Country Code: TI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKN01000000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 12/23/2023
• Supplement Dates Manufacturer Received: 02/20/2024; 02/20/2024
• Supplement Dates FDA Received: 02/21/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male