MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL.

Model Number	71453172
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery when the instrument was outside the patient.The physician was at the tibial insertion stage of a lgn ps high flex xlpe sz 1-2 12mm.The tibial insert was inserted into the baseplate and impacted with the inserter tool.The insert did not lock down flush with the baseplate.Then, it was removed and the lock mechanism on both parts was thoroughly cleaned.This was repeated 3 times and then a replacement insert was opened which locked in on the first attempt.The procedure was successfully completed without delay using a smith and nephew back up device.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: 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 attempted use.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 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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should 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: LGN PS HIGH FLEX XLPE SZ 1-2 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL.
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11773706
• Report Number: 1020279-2021-03737
• Device Sequence Number: 17088449
• Product Code: JWH
• UDI-Device Identifier: 00885556486894
• UDI-Public: 00885556486894
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2026
• Device Model Number: 71453172
• Device Catalogue Number: 71453172
• Device Lot Number: 16FM13054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1