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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source:(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: unk tmt augment loy unk, mdr: 3005751028-2021-00046.

Event Description

A journal article was retrieved from south african orthopaedic journal (2020) that reported a retrospective study from south africa that looked at the outcomes of revision hips using trabecular metal components that were performed at groote schuur hospital.The purpose of the study was to describe the total number of hip arthroplasty surgeries over five years and the ratio of revision to primary hip arthroplasty and indications for revision.The study reviewed 16 revision hips (14 patients) revised with tm revision components.The manufacturer of the initial products were not provided.The indication for revision was aseptic loosening and liner wear.The study population had a mean age of 61 years at time of surgery (range 38-86 years).The average duration of follow-up was 18.5 months (1.8-39.2 months).The study reported a (b)(6)-year-old female patient (patient 5 from table 2) had an initial right total hip arthroplasty with an unknown uncemented stem and cup.The patient was revised fifteen years post procedure with a tm revision cup and two screws due to aseptic loosening.The patient was re-revised within 3 months due to instability, fixation failure, and paprosky 3a defect.The patient was revised again due to instability and fixation failure of the tm cup and augment in which a new tm cup cage construct was placed.During the revision, the cup and augment were found to have no osseous integration.There was no sign of infection at any stage and the reason for early failure of fixation was thought to be instability of the construct.The patient continues to be monitored and there is no sign of loosening of the cup cage construct at final follow-up (x-rays available).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.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.

Event Description

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

• Brand Name: UNK TMARS SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 11749248
• MDR Text Key: 248152152
• Report Number: 3005751028-2021-00045
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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: 04/07/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention