MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. RT-PLUS MODULAR IMPLANT (UNKN. PART); PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

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

Patient Problem No Information (3190)

Event Date 08/13/2020

Event Type  Injury  

Event Description

It was reported that, after a tka surgery, the rt- plus modular implant loosened.The adverse event was addressed with a revision surgery to exchange the implant.The current state of patient is unknown.

Manufacturer Narrative

Results of investigation: it was reported that an rt modular knee system was revised due to loosening of the implants.The parts, used in treatment, were returned for investigation.The femoral and tibial component show a lot of bone cement on the surface.The tibial insert shows signs of wear, most likely due to a malalignment of the components.This might have happened through the loosening of the components.The part and batch numbers of the tibial and femoral component cannot be obtains as they are covered by the bone cement.Only with the allowance of destructive analysis or the patients charts, the batch records could be reviewed.The part and batch number of the insert however, was known.A batch record review did not show any deviations from standard manufacturing processes.A complaint history review did not show any further complaint for the batch in scope.The failure of loosening, followed by a revision is covered in the risk management files.Also, loosening of components is mentioned in the ifu (lit.No.12.24, ed.07/10) as a potential risk.The report of the revision surgery was provided.A medical assessment concludes that intraoperatively an instability and the loosening of the components could be confirmed.However, to root cause for the reported loosening cannot be independently confirmed, and it cannot be concluded that the reported instability and loosening were associated with a mal-performance of the implant.If further information becomes available, this complaint will be reassessed.To date, no further actions are deemed necessary.Smith and nephew will monitor the devices for further similar issues.The devices will be retained.

• Brand Name: UNKN. RT-PLUS MODULAR IMPLANT (UNKN. PART)
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10526074
• MDR Text Key: 206720113
• Report Number: 9613369-2020-00173
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K023667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82