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

Catalog Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Joint Laxity (4526); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 02/01/2011

Event Type  Injury  

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.Lanting, b.A., mccalden, r.W., & naudie, d.D.(2011).Dislocated polyethylene inserts in fixed-bearing total knee arthroplasty.The journal of arthroplasty, 26(2), 339-e1.Doi:10.1016/j.Arth.2009.11.014.

Event Description

"it was reported that on literature review "dislocated polyethylene inserts in fixed-bearing total knee arthroplasty", 1 patient presented an acutely painful swollen left knee.The patient had an extension lag of 20° with varus-valgus laxity and an audible noise suggesting metal-on-metal articulation.Radiographs were obtained and demonstrated a dislocated polyethylene insert 14 years after a tka procedure using a genesis l implants.The event was treated with a revision surgery.During the revision surgery there was significant metallosis in the synovial tissues and significant damage to the tibial baseplate.The patellar tendon had slight damage but remained intact.Intraoperative cultures were negative.The patient had an uncomplicated postoperative course and at 18 months had a range of motion of 0° to 115°.No further information is available.".

Manufacturer Narrative

G3: date received by manufacturer was mistakenly assigned as may 8th, 2023 but the actual revised aware date is october 11th, 2023.

• Brand Name: UNKNOWN GENESIS I 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: 17916213
• MDR Text Key: 325443895
• Report Number: 1020279-2023-01934
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• 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
• 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: 73 YR
• Patient Sex: Male