MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE TIB BASEPLATE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).¿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: doi.Org/10.3390/jcm12134356.Carulli, c., innocenti, m., tambasco, r., perrone, a., & civinini, r.(2023).Total knee arthroplasty in haemophilia: long-term results and survival rate of a modern knee implant with an oxidized zirconium femoral component.Journal of clinical medicine, 12(13), 4356.

Event Description

It was reported that on literature review "total knee arthroplasty in haemophilia: long-term results and survival rate of a modern knee implant with an oxidized zirconium femoral component", 1 patient, due to recurrent bleedings, had an early mechanical loosening of the femoral and tibial component 4 years after a tka procedure using genesis ll implant system.This issue was solved with a revision surgery with cementless stems and a higher constraint implant.No further information is available.

Manufacturer Narrative

Internal complaint reference number: (b)(4).Section h6 (health effect - clinical code) was corrected.

• Brand Name: UNKN GENESIS II TOTAL KNEE TIB BASEPLATE
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, 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: 19103049
• MDR Text Key: 340102888
• Report Number: 1020279-2024-00752
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/14/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention