MAUDE Adverse Event Report: BIOMET MICROFIXATION TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT; FOSSA IMPLANT

Model Number N/A

Device Problem Device Abrasion From Instrument Or Another Object (1387)

Patient Problem Pain (1994)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.The customer reports the part and/or lot number of the fossa screws that were explanted are unknown.If additional product information is received, additional medwatch reports will be submitted.

Event Description

The sales associate reported a revision due to pain.Additionally, it was reported that the fossa shows marks of abrasion at the edge, after three months of implantation.

Manufacturer Narrative

The product was returned for evaluation.Based on the evaluation, there was no failure mode that could be determined.Functional testing revealed that the device was implanted correctly.The most-likely underlying cause for the revision surgery taking place was determined to be pain the patient was having due the medical conditions associated with the patient.There was no indications of a manufacturing defect.

• Brand Name: TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT
• Type of Device: FOSSA IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5504458
• MDR Text Key: 40482249
• Report Number: 0001032347-2016-00129
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 527660A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR