MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 9M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	71421536
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee replacement surgery, while implanting the 3-4 9mm insert, the insert couldn't be locked well with base plate.A same code insert was used to complete the surgery.A delay of less than 30 minutes.
Additional Manufacturer Narrative
It was reported that during a knee replacement surgery, while implanting the 3-4 9mm insert, the device could not be locked well with base plate.A same code insert was used to complete the surgery.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail probably from the attempt of insertion.Dimensional analysis could not be performed as the damage/deformation at several features of the device would not allow for accurate measurement.There is no information that would suggest the device failed to meet specifications.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.Potential causes of the reported event could include but are not limited to size of device used, surgical technique or procedural/user 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.

• Brand Name: GII CR DEEP FLEX ISRT S3-4 9M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10423613
• Report Number: 1020279-2020-04035
• Device Sequence Number: 16878462
• Product Code: JWH
• UDI-Device Identifier: 03596010512444
• UDI-Public: 03596010512444
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041825
• 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): 10/21/2020

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: 71421536
• Device Catalogue Number: 71421536
• Device Lot Number: 19EM09069
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR