MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TAPERLOC STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.The following could not be completed with the limited information provided: device code - unknown, expiration date - unknown, date implanted - unknown, pma/510(k) number ¿ unknown, manufacture date ¿ unknown.This report is 1 of 2 mdrs for the same event (reference 3002806535-2016-00161 & 00162).Remains implanted.

Event Description

It was reported that patient underwent a total hip arthroplasty on an unknown date.Subsequently, an acetabular revision procedure was performed on (b)(6) 2016 due to elevated metal ion levels.During the procedure, the femoral stem was explanted after the surgeon could not remove the taper adapter.It was further reported that during replacement of the femoral stem, the surgeon chose to use cement on the distal portion of an uncemented stem despite being familiar with the surgical technique.

• Brand Name: UNKNOWN TAPERLOC STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5538009
• MDR Text Key: 41555781
• Report Number: 3002806535-2016-00162
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKONWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other