MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE

Catalog Number UNKN01200215

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/27/2021

Event Type  Injury  

Event Description

It was reported that, after a tka, the patient presented with painful from initial surgery on (b)(6) 2018.A revision surgery was performed on (b)(6) 2021, and was noted that the lgn cr high flex xlpe sz 7-8 9mm insert was pitted and the tibial baseplate was loose.The current health status of patient is unknown.

Event Description

It was reported that, after a tka, the patient presented with painful from initial surgery on (b)(6) 2018.A revision surgery was performed on (b)(6) 2021, and was noted that the lgn cr high flex xlpe sz 7-8 9mm insert was pitted and the tibial baseplate was loose.The femoral component was also extracted secondary to loosening.The current health status of patient is unknown.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, x-ray revealed early lucency at the medial tibial tray and bone scan showed increased update throughout the knee; however, the requested surgical records and x-rays are not available.Without the requested documentation, the clinical root cause of the pain and loosening cannot be concluded.The patient impact beyond the revision cannot be determined.No further medical assessment can be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.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 but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, and 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.We consider this investigation closed.

• Brand Name: UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE
• Type of Device: UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11832596
• MDR Text Key: 251114093
• Report Number: 1020279-2021-04357
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01200215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention