MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number 71420832

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

It was reported that during a tkr, the gii ps insert sz 5-6 11mm was unstable once placed between the femoral and tibial components.The area was cleaned off before placing the insert, and the insert was positioned using the tibial impactor, this was done multiple times but the insert continued to be unstable and not fitting properly.The procedure was finished using a back-up insert from smith and nephew, which have no issue once positioned.A delay of less than or equal to 30mins was reported.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned insert confirms minor damage to the lock detail, more than likely from attempting to snap into the tibial component.There is debris still adhere around the groove of the part.The visual also confirms some scratches on the surface of the insert.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.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 5-6 11MM
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11794909
• MDR Text Key: 249666702
• Report Number: 1020279-2021-03886
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010209658
• UDI-Public: 03596010209658
• Combination Product (y/n): N
• PMA/PMN Number: K951987
• 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: 07/13/2021

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
• Device Operator: Health Professional
• Device Model Number: 71420832
• Device Catalogue Number: 71420832
• Device Lot Number: H2001579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1