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

Model Number N/A

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem Unspecified Infection (1930)

Event Date 03/09/2015

Event Type  Injury  

Event Description

The sales associate reported the original surgery was (b)(6) 2015, during this case the initial implant did not fit the patient's anatomy well.The surgeon attempted to modify the implant, however during modification the implant broke.The second/back-up implant was implanted and no adverse events were reported.On (b)(6) 2015 the back-up implant was explanted due to infection.The surgeon is requesting a new implant for this patient.No pathology or operative reports have been provided, the type of infection is unknown at this time.

Manufacturer Narrative

Review of device history records show that 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.File one of three for the same event.

• Brand Name: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Type of Device: HTR
• 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: 4691972
• MDR Text Key: 5643971
• Report Number: 0001032347-2015-00173
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: N/A
• Device Catalogue Number: PM616069
• Device Lot Number: 584250
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2015
• 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