MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI HIRSCH LEFT FRONTAL SPENOID PARIETAL TEMPORAL IMPLANT; HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that though the cut edges were acceptable, the hard tissue replacement-patient matched implant (htr-pmi) could not be placed because the brain would not fit; the implant was about three centimeters away.The surgeon alleges the curvature of the implant was wrong.According to the surgeon, the design was created too shallow."a swelling of the brain lay according to the surgeon not available after removal of the own, osteolytic lid." the operation was not completed with another device.Neither the first choice nor the backup implants fit.The patient was closed without an implant.The duration of the surgical delay is unknown.No additional patient consequences were 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.The two implants were returned in a biohazardous condition and therefore only visual inspection could be performed.Visual inspection revealed no abnormalities in the manufactured part.Device history record (dhr) was reviewed and no discrepancies were found.The most likely cause of the complaint could not be determined as the manufacturer could not recreate the user problem.Potential causes could be due to changes in the patient¿s anatomy after the ct scan was taken or improper bone removal.The instructions for use (ifu) for this product states in the warnings section that ¿this device has been designed to fit the defect existing at the time of the ct scan and implant fabrication.Changes in the patient¿s anatomy occurring after the ct scan as well as the use of the implant after such changes may result in a suboptimal fit within the defect.Improper selection, placement, positioning, and fixation of the htr polymer implant can cause a subsequent undesirable result.The surgeon is to be familiar with the implant and the surgical procedure prior to performing surgery.Intraoperative shaping and sizing of the implant can be critical to the cosmetic success of the procedure, as improper shape and size can result in a noticeable undesirable prominence or possible disfigurement at or near the implant site.¿ a summary of the investigation has been sent to the complainant.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.

• Brand Name: HTR-PMI HIRSCH LEFT FRONTAL SPENOID PARIETAL TEMPORAL IMPLANT
• Type of Device: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7178674
• MDR Text Key: 96853795
• Report Number: 0001032347-2018-00019
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: PK924935
• 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: 06/26/2018

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: Physician
• Device Expiration Date: 10/26/2020
• Device Model Number: N/A
• Device Catalogue Number: PM620093
• Device Lot Number: 790580
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR