MAUDE Adverse Event Report: ZIMMER TMT TM ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, RIGHT POSTERIOR / LEFT ANTERIOR; COMMON DEVICE NAME

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

It was reported that the patient had an initial left hip arthroplasty on an unknown date.Subsequently, the pmi group is requesting a possible custom triflange acetabular component for a revision on (b)(6) 2017 due to bone reabsorption.No further information has been provided.

Manufacturer Narrative

No device was returned for evaluation, therefore only a device history review was performed.Device history records were reviewed for the component and no deviations or anomalies were found.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Attempts were made to obtain additional information.There is no information whether the revision surgery was conducted.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

• Brand Name: TM ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, RIGHT POSTERIOR / LEFT ANTERIOR
• Type of Device: COMMON DEVICE NAME
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 6973581
• MDR Text Key: 90104932
• Report Number: 3005751028-2017-02725
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00489440000
• Device Lot Number: 62955475
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention