MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 {} RIGHT; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71420184
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery (bilateral knee replacement), a component for the right side was implanted in the left knee.After explantation of the device, there was some damage (bone loss), to solve this problem the bone was covered with additional cement.Delay greater than 30 min.No back up was available.
Event or Problem Description
It was reported that during surgery (bilateral knee replacement), a component for the right side was implanted in the left knee.After explantation of the device, there was some damage (bone loss), to solve this problem the bone was covered with additional cement.Because of the mixup previously descrived, the devices for the right knee were no longer available, it was resolved to use a different size system in order to complete the procedure.Delay greater than 30 min.No back ups were available.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is a right leg device.The device has cement stuck to the backside and has numerous scratches from implantation.The device was manufactured on 2018.The clinical / medical investigation concluded that no relevant clinical medical information was provided to conduct a thorough medical assessment.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause of this event is likely a user error.The incorrect hand device was used during surgery.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GNS II CMT TIB SIZE 4 {} RIGHT
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9532455
• Report Number: 1020279-2019-04684
• Device Sequence Number: 13556016
• Product Code: JWH
• UDI-Device Identifier: 03596010206343
• UDI-Public: 03596010206343
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71420184
• Device Catalogue Number: 71420184
• Device Lot Number: 18KM18740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 12/17/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/16/2020; 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR