MAUDE Adverse Event Report: BIOMET MICROFIXATION HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT; HTR-PMI IMPLANT PMMA/PHEMA/CA 1PIECE

Model Number N/A

Device Problems Fitting Problem (2183); Patient-Device Incompatibility (2682)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/28/2014

Event Type  Injury  

Event Description

Htr pmi implant did not fit and had to be altered during surgery.Additional information was received suggesting that patient moved during the initial ct scan for the custom implant and that the post op ct did not match the initial ct.The back up and skull model will be returned for evaluation.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.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.

Manufacturer Narrative

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.The design and inspection scans were reviewed and the implants were found to be manufactured according to the design requirements.The most likely underlying cause of the complaint is patient movement on the ct scan used for design of the implant.The surgeon chose to approve the use of the scan.The original report stated the device would be evaluated, the implant was not returned for evaluation as it remains implanted in the patient.

• Brand Name: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Type of Device: HTR-PMI IMPLANT PMMA/PHEMA/CA 1PIECE
• 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 coldwater ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4261133
• MDR Text Key: 5008832
• Report Number: 0001032347-2014-00396
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM615689
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2015
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other