MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420818
Medical Device Problem Codes	Defective Device (2588); Positioning Problem (3009)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka surgery, the product narrow was used, and the insert 3-4 11mm could not be placed.The procedure finished with a smith and nephew backup device.No surgical delay reported.No patient harm reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that during a tka surgery, the product narrow was used, and the insert 3-4 11mm could not be placed.The procedure finished with a smith and nephew backup device.No surgical delay or patient harm reported.The affected genesis ii ps insert, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail probably from the attempted insertion.Dimensional analysis could not be performed as the damage/deformation on the part would not allow for accurate measurement.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 relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to limited to surgical technique 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: GII PS INSERT SZ 3-4 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10604096
• Report Number: 1020279-2020-04942
• Device Sequence Number: 2941353
• Product Code: JWH
• UDI-Device Identifier: 03596010209580
• UDI-Public: 03596010209580
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 71420818
• Device Catalogue Number: 71420818
• Device Lot Number: 19FM19794
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR