MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI LF FRT SP PAR T; HARD TISSUE REPLACEMENT

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 02/04/2014

Event Type  Injury  

Event Description

Biomet (b)(4) reports the size and shape of an htr implant did not match the defect.

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 refused to return the requested implant, however, post-operative scans were available and are being reviewed by the quality engineering team.There is currently no indication that the product was manufactured outside specifications determined by the patient's initial pre-operative ct scans.No non-conformances were identified during the manufacture of this implant.This product is manufactured for one particular patient only based on their anatomy at the time of the ct scan.As anatomy and tissue can change over time, the instructions for use (ifu) that accompanies the distribution of this product indicates that some modifications may be required.The design and manufacturing processes have been reviewed and no discrepancies or non-conformances have been identified.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.

• Brand Name: HTR-PMI LF FRT SP PAR T
• Type of Device: HARD TISSUE REPLACEMENT
• 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: 3644023
• MDR Text Key: 4204781
• Report Number: 0001032347-2014-00049
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PK953385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2019
• Device Model Number: N/A
• Device Catalogue Number: PM614762
• Device Lot Number: 163791
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2014
• 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): Hospitalization