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

Catalog Number UNKN01200116

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

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 10/10/2017

Event Type  Injury  

Event Description

Us legal mdl: it was reported that, after a right tka was performed on (b)(6) 2015, the plaintiff experienced severe pain, discomfort, and mechanical loosening of right tibial component.A revision surgery was performed on (b)(6) 2017 to treat this adverse event.During the revision surgery, the tibial component baseplate and the tibial insert were explanted.The plaintiff outcome is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the clinical root cause of the reported loosened tibial component and central tibial lytic lesion cannot be concluded.The patient impact beyond the pain, revision and post-op convalescence period cannot be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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 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.

• 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
• MDR Report Key: 12453600
• MDR Text Key: 270822218
• Report Number: 1020279-2021-06794
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR