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

Model Number	71420816
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, a 9mm insert would not lock tightly in baseplate.A backup insert was used to complete the procedure and there was no injury reported.It is unknown if a delay occurred.
Additional Manufacturer Narrative
It was reported that during surgery, a 9mm insert would not lock tightly in baseplate.A backup insert of the same size was used to complete the procedure and there was no injury or delay 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.
Event or Problem Description
It was reported that during surgery, a 9mm insert would not lock tightly in baseplate.A backup insert of the same size was used to complete the procedure and there was no injury or delay reported.

• Brand Name: GII PS INSERT SZ 3-4 9MM
• 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: 10648200
• Report Number: 1020279-2020-05239
• Device Sequence Number: 14104734
• Product Code: JWH
• UDI-Device Identifier: 03596010209573
• UDI-Public: 03596010209573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/16/2020

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: 71420816
• Device Catalogue Number: 71420816
• Device Lot Number: 19LM11240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/13/2020
• Supplement Date Received by Manufacturer: 10/14/2020; 12/02/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 10/16/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420164 / H1915073
• Patient Age: 73 YR
• Patient Weight: 63