MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI TIB BASE SZ 2 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71935194

Device Problem Connection Problem (2900)

Patient Problem Injury (2348)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, two inserts did not fit into the jii uni tibial baseplate sz 2 lm/rl.The surgeon then decided to explant the plate and insert a device from a competitor brand.The surgery was successfully completed.It is unknown if this caused surgery to delay.The patient outcome is unknown.

Manufacturer Narrative

Results of investigation: it was reported that during surgery, two poly inserts were tested but would not fit the tibial baseplate.Plate was explanted and a competitors device was implanted which caused a posterior bone stock loss.Procedure was concluded without an injury or a delay.It was reported that during surgery, two poly inserts were tested but would not fit the tibial baseplate.Plate was explanted and a competitors device was implanted which caused a posterior bone stock loss.Procedure was concluded without an injury or a delay.The associated device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to size of device used or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JII UNI TIB BASE SZ 2 LM/RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10651652
• MDR Text Key: 210489706
• Report Number: 1020279-2020-05258
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556578735
• UDI-Public: 00885556578735
• Combination Product (y/n): N
• PMA/PMN Number: K152315
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71935194
• Device Catalogue Number: 71935194
• Device Lot Number: 19EAP0202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CN: 71935205, LN 19GAP0117B (X2); CN: 71935205, LN 19GAP0117B (X2)
• Patient Outcome(s): Required Intervention