MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR*PMI GREB LEFT MANDIBULAR IMPLANT; CUSTOM DEVICE

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00557, 0001032347-2019-00558.Concomitant medical products: htr*pmi greb left mandibular implant, part#: pm622502, lot#: 937360.Htr*pmi greb chin implant, part#: pm622504, lot#: 937350.Htr*pmi greb right mandibular implant, part#: pm622505, lot#: 937340.The user facility is foreign; therefore a facility medwatch report will not be available.Foreign report source: (b)(6).

Event Description

It was reported that a custom mandible implant fractured upon implantation and that a custom chin implant had to be altered due to fit issues.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The design vendor and manufacturer of these parts (cas) was notified of the fit and cracking issues and performed an investigation and provided their results.The design vendor did not find any evidence that the design or manufacturing of this part contributed to the fit or cracking issues experienced.An image was provided, which showed one of the cracked implants.The dhrs for these products were reviewed, and no non-conformances were found.There are no indications of manufacturing defects.For patient matched htr-pmi implants (pmxxxxxx) and the previous year (from the notification date) regarding intraoperative cracking of the implant, there is a complaint rate is (b)(4) which is no greater than the occurrence listed in the application fmea.For patient matched htr-pmi implants (pmxxxxxx) and the previous year (from the notification date) regarding fit issues, there is a complaint rate is (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not be determined.Upon review of the provided intra-operative picture, it appears the three screws shown were inserted into the implant on an angle, rather than directly perpendicular into the implant.It also appears that the screws were inserted close to the edges of the implant.It is possible that these issues contributed to the failures of the devices.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.The following fields were updated: date of this report, describe event or problem, expiration date, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, device manufacture date, method code, results code, conclusions code, and additional narratives/data.

• Type of Device: CUSTOM DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9512772
• MDR Text Key: 184053681
• Report Number: 0001032347-2019-00556
• Device Sequence Number: 1
• Product Code: LZD
• 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
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2022
• Device Model Number: N/A
• Device Catalogue Number: PM622502
• Device Lot Number: 937360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention