MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN SCREW

Model Number N/A

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that upon review of the patient's scans, it was discovered that the condyle is in the ear canal due to incorrect placement of the fossa component, the mandible screws are not bicortical and the lower screw on the mandible looks loose.Patient was experiencing pain and swelling.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet complaint #: (b)(4).Concomitant medical products: medical devices: zimmer biomet mandible catalog #: ni; lot #:ni.Zimmer biomet fossa catalog #: ni; lot #:ni.Foreign: (b)(6).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: 0001032347-2022-00177 and 0001032347-2022-00178.

Manufacturer Narrative

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

Event Description

It was reported that the implant was removed.Both the fossa and condyle elements were too near and pressing on the ear canal.The condyle element was articulating with the posterior part of the fossa and not the middle part as would be recommended.The implant was removed intact.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6a - (b)(6) 2014.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided for the mandible and fossa components.A definitive root cause cannot be determined.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.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN SCREW
• Type of Device: SCREW
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14592153
• MDR Text Key: 293290007
• Report Number: 0001032347-2022-00179
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female