MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIB BASE SZ 3 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 00584200301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Date of implant is an estimate as only the month of the surgery was provided.

Event Description

It was reported that a patient underwent a revision surgery of a zuk uni.The tibial component and insert were replaced.

Event Description

The revision was performed to correct the anterior slope.

Manufacturer Narrative

The associated complaint devices were not returned due to devices are still implanted.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A clinical analysis indicates that the patient was revised 2 months post tka, due to report of having an "unsatisfactory result." it has been communicated via email that the surgeon stated that he cut the tibia with anterior slope, and therefore revised the tibia to correct the slope.Therefore, a procedural variance cannot be eliminated as a contributing factor in root cause for performing the revision.No explants or supporting clinical/medical documentation will be provided.Due to insufficient clinical information, no further clinical assessment is able to be performed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TIB BASE SZ 3 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7037765
• MDR Text Key: 92283546
• Report Number: 1020279-2017-01037
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

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 Catalogue Number: 00584200301
• Device Lot Number: 63397781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 11/07/2017
• Supplement Dates FDA Received: 12/11/2017; 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR