MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN FOSSA SCREWS; PLATE, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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: 0001032347-2021-00339, 0001032347-2021-00341.Medical products: ce99-201125, left pm-tmj & model, part#: tmjpm-3257, lot#: 039420.Unknown, mandible screws, part#: ni, lot#: ni.Report source: (b)(6).

Event Description

It was reported that a patient underwent a removal of temporomandibular joint implants on the left side eight (8) weeks following implantation due to infection and perforation of the ear canal.Upon implantation, bleeding was seen in the left ear toward the end of the operation.The implanting surgeon said the wound would be treated by colleagues in the ent department.It was reported that no further information is available.

Event Description

It was further reported that within the surgery the patient was revised of the fossa components and fossa screws.These components were infected and the screws were noted as moving.The other components were left implanted with no issues noted at the time of the surgery.

Manufacturer Narrative

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

Manufacturer Narrative

Upon reassessment of the event, it was determined that the product did not cause or contributed to the event, the screws are packed as non sterile from zimmer biomet and are required to be processed as sterile at the health care facility before implantation.Hence, the initial report submitted needs to be voided.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: UNKNOWN FOSSA SCREWS
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12024346
• MDR Text Key: 261343490
• Report Number: 0001032347-2021-00340
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR