MAUDE Adverse Event Report: ZIMMER TMT TM ACETABULAR AUGMENT

Model Number N/A

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/05/2017

Event Type  Injury  

Event Description

It was reported that the surgeon found it difficult to put the screw through the augment hole.It caused putting more pressure into the implant which slightly changed the location of both acetabular cup and the augment.In result (b)(6) had to remove both components from the patient.The tm augment is the only zimmer biomet (b)(4) designed controlled part.

Manufacturer Narrative

It was reported the surgeon found it difficult to put the screw through the augment hole.It caused putting more pressure into the implant which slightly changed the location of both acetabular cup and the augment.In result the surgeon had to remove both components from the patient.This event resulted in extended surgery time of 30-40 minutes.No harm or injury to the patient reported, however an unanticipated surgical complication occurred.The surgeon was not able to achieve appropriate level of stability and surgery was completed with another approach.Based on the investigation results, it is not suspected that the tm augment failed to meet specifications.The investigation could not verify or identify any evidence of tm augment contribution to the reported problem.This investigation is considered closed at this time; however, should additional information be received, this report shall be updated.

Event Description

No additional information reported.

Manufacturer Narrative

During review activities it was noted the item number originally associated to the lot number was incorrect.The item number has been corrected and the following fields updated.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

A hg bone screw and an augment were returned for evaluation.Visual examination of the returned screw showed damage on the major diameter of the thread form.Additionally, a portion of the thread form had been polished, which indicates that the screw had been fully seated.Multiple impaction marks were observed on the augment.However, it is unknown when impactions occurred and their contribution to the reported event cannot be determined.While inserting the screw with aligning with the spiral marks of the augment, a piece of bone cement was blocking.It is unknown when the bone cement was cured, therefore, it is unknown if the bone cement blocked the screw during surgery.The screw was inserted with an angle and rubbing against the augment, contributing to the reported event.However, it was not determined what caused the screw to be inserted in an angle.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause for the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TM ACETABULAR AUGMENT
• Type of Device: TM ACETABULAR AUGMENT
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 6878769
• MDR Text Key: 86747065
• Report Number: 3005751028-2017-02711
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K042871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00489405415
• Device Lot Number: 63359613
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/06/2017; 09/06/2017; 04/20/2020
• Supplement Dates FDA Received: 12/18/2017; 03/06/2020; 04/21/2020
• 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: 50 YR