MAUDE Adverse Event Report: ZIMMER TMT FEMORAL AUGMENT BLOCK DISTAL ONLY; FEMORAL AUGMENT BLK

Catalog Number 00549003624

Device Problems Unstable (1667); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Device was not returned for evaluation.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.There is no indication that the augment block failed to meet specification or perform as expected.Tm femoral augment block, is the devices that was used as bone filling.Should additional information be obtained to further this investigation, this report shall be updated.Not returned by the hospital.

Event Description

It was reported that a patient underwent an initial knee procedure on (b)(6) 2015.The proximal portion of the offset stem extension was sheared off inside the a/p wedge implant that was in the patient.Subsequently, the patient was revised on (b)(6) 2017 due to failure of the implant.Implant failure no longer allowed the knee to be stable or functional on any level.Tm femoral augment block is the devices that was used as bone filling.This is the tmt design controlled part.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: FEMORAL AUGMENT BLOCK DISTAL ONLY
• Type of Device: FEMORAL AUGMENT BLK
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7068568
• MDR Text Key: 93286101
• Report Number: 3005751028-2017-02743
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 00549003624
• Device Lot Number: 62468394
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• 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: 68 YR