MAUDE Adverse Event Report: BIOMET UK LTD. RECAP FEM HD COCR CEMENTED DIA 44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 01/15/2014

Event Type  Injury  

Event Description

It was reported by the hospital that patient underwent a hip surgery on an unknown date.Revision procedure was performed on (b)(6) 2014 due to pain.Upon removal of the implant, it was found that the main peg had sheared off and was left in the bone.No further information has been received.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Expiration date - unknown.Implant date - unknown.Manufacture date - unknown.Item has been requested to be returned.Upon receipt of item and product evaluation, a follow-up mdr will be sent to the fda.

Manufacturer Narrative

The returned implants were evaluated and it appears the fracture of the stem was a result of fatigue.Evidence of two wear stripes and the extensive wear damage on the femoral head suggest that possible sub optimal positioning or joint laxity was a factor in the eventual component failure.It should also be noted that some of this wear damage could have occurred after failure of the stem.It was stated in the relevant "indications for use" at the time that the components were manufactured that: ¿fatigue fracture of components can occur as a result of loss of fixation, trauma, malalignment, bone resorption, trauma, or excessive weight.The root cause behind this failure mechanism is unclear, although it is possible that suboptimal cementing may have been a contributing factor.Further surgical information, radiographs and the missing portion of the stem would be necessary to determine the definite cause.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: RECAP FEM HD COCR CEMENTED DIA 44MM
• 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: sian rogers ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 3612230
• MDR Text Key: 4094398
• Report Number: 3002806535-2014-00040
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2016

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: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 157244
• Device Lot Number: 1322572
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 02/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2014; 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2007
• 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