MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN PROFIX TOTAL KNEE FEMORAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that on literature review "atraumatic fracture of the femoral component of a cemented total knee arthroplasty", 1 patient started suffering from severe left knee pain without trauma, 16 years after a tka procedure using a profix knee system.The range of motion was 0 to 90 degrees, patient had walking difficulty and needed to use a wheelchair.The event was resolved with a revision surgery, where a fracture of the medial femoral condyle of the profix femoral component implant was found.The endo-modelular rotational implants from waldemar link gmbh were implanted instead.Cultures obtained to rule out infection by protocol became negative.Finally, hemostasis was reviewed before wound closure.Drains were not used.Postoperatively, recovery was good and pain relieved within the first days.After one year of follow-up, the patient was pain-free and very satisfied with the revision procedure.He walked without external aids.He presented an excellent functionality.No further information is available.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Doi.Org/10.2106/jbjs.Cc.22.00641.Pujol, o., reverté, m., pijoan, j., minguell, j., joshi-jubert, n., & castellet, e.(2023).Atraumatic fracture of the femoral component of a cemented total knee arthroplasty: a case report.Jbjs case connector, 13(1), e22.

Manufacturer Narrative

Corrected data: h6 (health effect - clinical code, investigation findings).Updated results of investigation: the device was not returned for evaluation.However, the photograph was reviewed, and revealed the device fractured.The clinical/medical investigation concluded that, the reported pain, decreased range of motion, and difficulty walking are consistent with findings associated with implant breakage.Based on information provided, the clinical root cause of the implant breakage cannot be definitively concluded.However, the osteolysis and loosening vs duration of service of the implant cannot be ruled out as contributing factors to the breakage.The impact to the patient is limited to the revision surgery and associated recovery period symptoms.Per the article, the patient was symptom-free one year post-operatively.Therefore, no further impact to the patient is presumed.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and product prints review could not be performed.A review of the instructions for use documents for knee systems revealed that break of implant has been identified in warnings and precautions section as a result of strenuous activity or trauma.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb and/or excessive forces.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: UNKNOWN PROFIX TOTAL KNEE FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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: 17987966
• MDR Text Key: 326306195
• Report Number: 1020279-2023-02036
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 74 KG