MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420816
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, the gii ps insert sz 3-4 9mm 3-8 easily comes out of the tibia.The procedure was completed, with a delay less than 30 min, using a s+n back-up device.No patient injuries and no other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the stated failure.The locking detail of the device is damage from attempted insertion.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 the complaint history did not reveal additional complaints for the listed batch.The production documentation was reviewed.No deviations from the standard manufacturing procedure were found.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 3-4 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11810793
• Report Number: 1020279-2021-04072
• Device Sequence Number: 11710553
• Product Code: JWH
• UDI-Device Identifier: 03596010209573
• UDI-Public: 03596010209573
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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 Model Number: 71420816
• Device Catalogue Number: 71420816
• Device Lot Number: J2001768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1