MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10MM; BONE SCREW

Model Number N/A

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation tmj system right fossa component, small catalog #: 24-6562, lot #: 377870c; biomet microfixation tmj system right titanium mandibular component, catalog #: 01-6545, lot #: 372370a; biomet microfixation "2.4mm" system ht cross-drive screw, 2.7x10mm, catalog #: 91-2710, lot #: ni; and biomet microfixation tmj system cross drive fossa screw, 2.0x7mm catalog #: 99-6577, lot #: ni; therapy date: unknown.(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00011, 0001032347-2019-00012, 0001032347-2019-00013, and 0001032347-2019-00015.

Event Description

It was reported by the patient that she did not have insurance that would cover the type of intervention needed.She¿s had more problems since being implanted than prior to implants; two years after implantation, she¿s experienced multiple episodes of blood coming from her ears and nose, coughing up blood, consistent swelling in her mouth, and constantly hearing squeaky noises throughout the day coming from the implant.She also stated her surgeon relocated to florida.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Functional testing and inspections could not be performed due to the product not being returned and no photographs, x-rays, scans or physician reports being provided.For these reasons, the complaint cannot be verified and the most likely underlying cause cannot be determined.There was no information provided to indicate that the reported hemoptysis and epistaxis is related to a malfunction or inability of the implants to function as intended.The instructions for use (ifu) for this product has adverse events that may occur following placement of the total tmj replacement system in the section titled adverse events: ¿ removal of components(s) including, but not limited to the following: - implant changes caused by loading and/or wear - degenerative changes within the joint surfaces from disease or previous implants - implant materials producing particles or corroding ¿ loosening or displacement with or without removal of the implant ¿ infection (systemic or superficial) ¿ foreign body or allergic reaction to implant components ¿ fossa wear through ¿ facial swelling and/or pain ¿ heterotopic bone formation ¿ ear problems ¿ dislocation the non-conformance report was reviewed, there are no non-conformances listed on the report for the tmj components.Device history record (dhr) review was unable to be performed for the screws as the lot numbers of the devices involved in the event are unknown.There are no indications of manufacturing defects.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00011-1, 0001032347-2019-00012-1, 0001032347-2019-00013-1, and 0001032347-2019-00015-1.

Event Description

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

• Brand Name: 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8219865
• MDR Text Key: 132199067
• Report Number: 0001032347-2019-00014
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K113512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 91-2712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention