MAUDE Adverse Event Report: BIOMET MICROFIXATION HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT; HTR PMMA

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Updated as additional information was received.The part number, lot number, expiration date, and manufacturing date were identified.The manufacturing history records for this part number were reviewed and no deviations were identified.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The part and lot history of the implanted unit is unknown; therefore, the device history records are unable to be reviewed.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.File one of three for the same event.

Event Description

The distributor reported that a htr pmma implant is being explanted due to ongoing infection issues related to its placement in the frontal sinus.The implant is scheduled to be replaced with a htr pekk implant, the date of the revision surgery is unknown at this time.

• Brand Name: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Type of Device: HTR PMMA
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4055873
• MDR Text Key: 15288027
• Report Number: 0001032347-2014-00288
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2012
• Device Model Number: N/A
• Device Catalogue Number: PM608801
• Device Lot Number: 777620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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