MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 8 LT; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71424008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in revision surgery of the procedure tka, the tibial component was failed.The procedure was completed without delay.Backup from smith&nephew was available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that per the complaint details, during the revision it was noted the ¿tibial component was failed¿.Reportedly, the procedure was completed with a backup component without delay, patient injury or other complications.However, s+n has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.The patient impact beyond the reported insert failure/use of the backup device during the tka revision could not be determined.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.No further medical assessment is warranted at this time.A review of complaint history did not revealed additional complaints for the listed device.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 and potential harm was previously identified.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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.We consider this investigation closed.

• Brand Name: LGN REV TIBIA BASE SZ 8 LT
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10188068
• Report Number: 1020279-2020-02678
• Device Sequence Number: 947903
• Product Code: JWH
• UDI-Device Identifier: 03596010546128
• UDI-Public: 03596010546128
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 71424008
• Device Catalogue Number: 71424008
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 06/23/2021
• 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