MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HEAD DIA36/ 0MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 12/05/2015

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.Expiration date ¿ unknown; device availability ¿ the device is reportedly available for evaluation; however, it has not been received by zimmer biomet (b)(4) to date.In the event that the device is received and evaluated, a follow-up report will be sent to the fda to provide results; manufacture date ¿ unknown.

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2015 due to pain and instability.During the procedure, the acetabular liner and femoral head were removed and replaced.The femoral head was replaced with competitor product.

• Brand Name: DELTA CERAMIC FEM HEAD DIA36/ 0MM T1
• 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: 5333323
• MDR Text Key: 34645518
• Report Number: 3002806535-2015-04192
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK131684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2015

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 2015040875
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/29/2015
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention