MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN GENESIS KNEE IMPLANT; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)

Event Date 10/06/2006

Event Type  Injury  

Event Description

"it was reported that on literature review ""fracture of femoral component in a resurfacing total knee arthroplasty"", 1 patient had gradually increasing pain and walking difficulty after a tka procedure using genesis implants.There was medial laxity and flexion from 08 degrees to 100 degrees with some crepitation.The event was resolved by revision surgery.At revision surgery, the femoral component was found broken just anterior to medial peg, at the junction between the trochlear flange and the medial condyle area.The polyethylene insert showed degradation changes under the fractured implant.The remaining femoral component and the tibial tray were both stable.The prosthesis was revised to another cemented ps implant.Patients outcome if known.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.Michos, j., rallis, j., & fassoulas, a.(2006).Fracture of femoral component in a resurfacing total knee arthroplasty.The journal of arthroplasty, 21(7), 1068-1071.Doi:10.1016/j.Arth.2005.10.024.

• Brand Name: UNKNOWN GENESIS KNEE IMPLANT
• 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: 17917316
• MDR Text Key: 325445313
• Report Number: 1020279-2023-01936
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• 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: 10/11/2023
• 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: 72 YR
• Patient Sex: Female