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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 04/16/2015

Event Type  Injury  

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No product has been returned.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.

Event Description

It was reported that patient was to undergo a total hip arthroplasty on (b)(6) 2015.After anesthesia was administered, it was discovered that the consignment set to be used in the procedure did not contain any femoral heads.The procedure was aborted and the patient awoke without any further complications.

• Brand Name: UNKNOWN ARCOS HIP
• 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: 4799752
• MDR Text Key: 19066107
• Report Number: 3002806535-2015-00231
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• 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: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention