MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METALCRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Investigation in progress.Device not returned.

Event Description

Revision due to dislocation.It was reported that a patient underwent an initial knee procedure on (b)(6) 2013.Subsequently the patient was revised on (b)(6) 2018 due to dislocation of right knee.Patient had fallen in kitchen dislocating knee arthrotomy.Trabecular metal tibial component is only the tmt design control part.

Manufacturer Narrative

Patient is a (b)(6) female, status post bilateral knees.Patient was found to be morbidly obese using the bmi calculator from the (b)(6) institute along with the patent¿s height and weight.A trabecular metal cruciate retaining monoblock tibia was a component used in the right knee primary total knee arthroplasty.It was reported that the patient¿s right knee was revised approximately 5 years after the primary surgery as a result of the patient falling and dislocating her right knee.No x-rays or imaging reports were made available for this investigation.The condition of the explanted tibial component was not reported nor was the device itself returned so ultimately the condition of the device remains unknown.And while it has not been confirmed through this engineering investigation that the tm tibial component had failed in any way, loosening of the device due to patient obesity is a known risk and therefore documented as a warning in the package insert.The patient labels from the revision surgery indicated the need for additional knee constraint which was provided by a zimmer biomet rotating hinge knee including tibial augment blocks and stem extensions.The complaint did not allege nor did this engineering investigation determine that the trabecular metal cruciate retaining monoblock tibia failed to perform as intended.This investigation by product development/post-market engineering is considered closed at this time.Should additional information become available, this investigation may be re-opened.

Event Description

Revision due to dislocation.It was reported that a patient underwent an initial knee procedure on (b)(6) 2013.Subsequently the patient was revised on (b)(6) 2018 due to dislocation of right knee.Patient had fallen in kitchen dislocating knee arthrotomy.Trabecular metal tibial component is the only tmt design controlled part.

• Brand Name: TRABECULAR METALCRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7799298
• MDR Text Key: 117692744
• Report Number: 3005751028-2018-00056
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00588604310
• Device Lot Number: 62240022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 145