MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIB BASE SZ 4 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 00584200401

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/12/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to an infection.No product issues suspected.

Manufacturer Narrative

The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TIB BASE SZ 4 LM/RL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8217845
• MDR Text Key: 132092044
• Report Number: 1020279-2019-00047
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556619773
• UDI-Public: 00885556619773
• Combination Product (y/n): N
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 00584200401
• Device Lot Number: 62150480
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR