MAUDE Adverse Event Report: ZIMMER TMT UNK TMARS SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

A journal article was retrieved from the journal of arthroplasty (2020) that reported a prospective study from (b)(6) that looked at the long-term outcomes of revision hip arthroplasty using tm augments for severe acetabular defects.The purpose of the study was to examine construct survivorship.The study reviewed 38 patients/hips revised using the tm acetabular revision system with screws and augments as needed with cementing of 2 of the tm cups.A posterolateral approach was used in all cases.The indication for revision was aseptic loosening in 34 cases and two stage revision for deep infection in 4 cases.The study population had an average age of 67.5 years (range: 48.0 to 84.7) with a mean follow-up of 7.3 years (range: 5.4 to 10.8).Radiographs and outcome assessment were conducted annually.The study reported 6 patients have had late postoperative complications requiring revision surgery; of which, 1 patient who was revised for aseptic loosening and augment hardware failure had extensive acetabular resorption after external beam radiotherapy for bowel cancer.

• Brand Name: UNK TMARS SHELL
• Type of Device: PROSTHESIS, HIP
• 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: 11676325
• MDR Text Key: 246594233
• Report Number: 3005751028-2021-00025
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2021

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 Model Number: N/A
• Device Catalogue Number: UNK TMARS SHELL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention