MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION,TM STANDARD PRIMARY PATELLA

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

Investigation in progress.Device was discarded by the hospital.

Event Description

It was reported that the patient was implanted with tm patella during left tka on (b)(6) 2018.On (b)(6) 2018, it was reported that the patient underwent a revision surgery.Alleged event description mentions, "nexgen tm patella dislodged from single peg hole and fell into the area anterior of the prosthesis(femur & tibial).Patient had to be re-admitted and undergo a revision surgery to remove said patella implant.Patient patella tendon was ruptured".

Event Description

Revision due to loosening.

Manufacturer Narrative

No device was returned for evaluation, therefore only a device history review was performed.A device history record was reviewed for the tm patella with part number 00587806541 and lot number 63911019, and no deviations or anomalies were found.A review of the implant's manufacturing record indicates that it was manufactured to specification.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Tm patella is the only component that is zimmer tmt design.Should additional information be obtained to further this investigation, this report shall be updated.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION,TM STANDARD PRIMARY PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7629597
• MDR Text Key: 112028461
• Report Number: 3005751028-2018-00036
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00587806541
• Device Lot Number: 63911019
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• 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: 58 YR