MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL POSTERIOR FEMORAL AUGMENT BLOCK; POSTERIOR FEMORAL BLOCK

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Osteolysis (2377); Test Result (2695)

Event Date 11/01/2017

Event Type  Injury  

Event Description

It was reported that the patient underwent initial surgery on (b)(6) 2015.Almost 2 years later patient complained that his knee still had pain subsequently patient was revised on (b)(6) 2017 due to pain, wear, implant disassociation, loosening, metalosis, osteolysis.Tm augment is the only tm design controlled part.

Manufacturer Narrative

Patient is a (b)(6) male, medium build, no height, weight or activity level was reported.Patient has a history of 5 surgeries on his left knee spanning a 13 year period which includes the primary surgery in 2004 through the fourth revision surgery in 2017.Complaint alleges pain in the left knee, implant wear, implant disassociation, loosening, metallosis and osteolysis.The patient was revised on (b)(6) 2017.An engineering investigation was conducted by product development.The evidence while limited and not overwhelmingly conclusive, suggests that the suspected damage was primarily concentrated on the medial side of the femoral component where both a 5mm distal femoral augment block and a 5mm tm posterior femoral augment block were attached.Damage included a raised lip surrounding the internal thread on the femoral component where the distal augment screw could have pulled out from the internal threads as well as damage to the visible edge of the medial tm posterior femoral augment block.In addition, there appeared to be wear marks on the medial side of the femoral component where the 5mm distal femoral augment block was once attached.This implies that at least the nexgen rhk/lcck femoral augment screw which attached the 5mm distal femoral augment block loosened at some point in time which allowed relative motion between the two components.However, the independent radiologist who assessed the images reported that there was no evidence of wear or metallic particles seen on the films.Loosening of the nexgen rhk/lcck femoral augment screw was likely a result of failing to use the required augment torque wrench, as specified in the surgical technique and package insert, which ensures proper tightening.Failing to use the appropriate instrumentation was reported in a follow-up email from the sales rep.The 10mm distal femoral augment was also reported as being separated from the femoral augment and although not unreasonable to expect given that the same instrumentation was used, the limited evidence provided in this complaint does not support this.This investigation by product development is considered closed at this time.Should additional information become available to further this investigation, this report shall be updated.

• Brand Name: TRABECULAR METAL POSTERIOR FEMORAL AUGMENT BLOCK
• Type of Device: POSTERIOR FEMORAL BLOCK
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7183961
• MDR Text Key: 97026666
• Report Number: 3005751028-2018-00004
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK040487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00549003601
• Device Lot Number: 62929061
• Other Device ID Number: N/A
• Date Manufacturer Received: 01/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention