MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE PAT COMP; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Date 11/06/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Doi: https://doi.Org/10.1016/j.Arth.2021.11.001.

Event Description

It was reported that, on literature review "survivorship comparisons of ultra congruent, cruciate-retaining and posterior-stabilized tibial inserts using a single knee system design: results from the australian orthopedic association national joint replacement registry" corresponding to data collected from 1999 to 2019, a total of 67523 patients underwent a primary tka surgery where genesis ii systems were implanted, 21635 had a cruciate-retaining insert, 33454 had a posterior stabilized insert and 12434 had a ultra-congruent insert.After the primary tka surgery, 114 patients who had cruciate-retaining insert, 148 patients who had posterior stabilized insert and 58 patients who had ultra-congruent insert, underwent a revision surgery due to patellar erosion.Current health status of the patients is unknown.Further information was not available.

Manufacturer Narrative

The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on the information provided, no further details will be available.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded, since the current health status of the patients is unknown.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 GENESIS II TOTAL KNEE PAT COMP
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 15552135
• MDR Text Key: 301270549
• Report Number: 1020279-2022-04349
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: No
• 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