MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR PMI R.T.1959 FRONTAL IMPLANT; MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Initial reporter also sent report to fda: the user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon was unsatisfied with the fit of the implant in that the implant was an inaccurate design overlapping in the forehead area.No known adverse event was reported.Attempts have been made and no further information has been provided.The surgeon reported the implant was an inaccurate design overlapping in the forehead area.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.This complaint could not be verified.The complaint is that the surgeon was dissatisfied with, quote: the inaccuracy on the side of a bifrontal implant.Design vendor of this part could not find any evidence that the design of this part contributed to the fit issues experienced.The manufacturing documents and inspections of this product was reviewed and there was no evidence to indicate that manufacture of this part contributed to the fit issues experienced.No post-operative x-rays, scans or physician's reports were provided.The dhr of this product was reviewed and no non-conformance was found.There are no indications of manufacturing defects.For patient matched htr-pmi implants (pmxxxxxx) and the previous year (from the notification date) regarding fit issues, there is a complaint rate of 0.4% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of this complaint could not be determined.A potential cause of this complaint could be a change in the patient¿s anatomy, after the scans were taken for the design of this product or the resection of the bone/tissue that was performed was different than the bone/tissue removal that was recommended.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: HTR PMI R.T.1959 FRONTAL IMPLANT
• Type of Device: MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8520429
• MDR Text Key: 142539943
• Report Number: 0001032347-2019-00229
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: N/A
• Device Catalogue Number: PM621542-A
• Device Lot Number: 876550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR