MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR *PMI CORSI LEFT FRONTAL PARIETAL TEMPORAL IMPLANT; HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.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 implant did not fit well.There were several possibilities that may have caused this issue, but it is thought that the implant was a bit off.It did not seem to have enough curve to it.When the implant was aligned against the anterior portion of the defect, the posterior side of the implant would lip up about four to five millimeter and vice versa.There was no way to get it to sit flush.So, the surgeon cut four centimeters off the posterior side and filled the gap with bone cement.There was a delay of approximately thirty minutes.No adverse events have been reported as a result of the malfunction.The surgeon was satisfied with the end result and no issues have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.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 product was returned and no functional tests or inspections could be performed.No post-operative x-rays, scans or physician's reports were provided.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Type of Device: HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8320844
• MDR Text Key: 135554187
• Report Number: 0001032347-2019-00096
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Model Number: N/A
• Device Catalogue Number: PM621333
• Device Lot Number: 862700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1