MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number 71453211

Device Problem Fitting Problem (2183)

Patient Problem Tissue Damage (2104)

Event Date 04/09/2020

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, the locking mechanism for lgn ps high flex xlpe sz 3-4 9mm implant did not match.The dysfunctional implant was removed from bone and a new one was used in the patient.Some tissue and ligaments had to be removed in order to explant the defective device.A delay of 30 min was reported.The patient was not injured beyond the reported event.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from the attempted insertion.The medical investigation concluded that two x ray photos were provided but they were preoperative and do not contribute to the root cause of the failure.Without the requested clinical information, the implantation report or the post implantation radiographs, the root cause of the locking mechanism mismatch cannot be determined.According to the product evaluation, the failure mode could not be confirmed.We cannot rule out a procedural variance vs user error as the likely cause of the reported event.Per report, a component was removed from the bone but this insert was locked into the baseplate.It is unknown the baseplate was also removed.In addition, there were reports of removing extra tissue and ligaments to adjust for this complaint.Without further details, we cannot conclude the impact to the patient.A backup device was available with no significant delay in the procedure.No further clinical/medical assessment is possible at this time.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/sizing issue or improper surgical technique.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10026854
• MDR Text Key: 189975300
• Report Number: 1020279-2020-01472
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71453211
• Device Catalogue Number: 71453211
• Device Lot Number: 19DM14562
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention