MAUDE Adverse Event Report: BIOMET UK LTD. RECAP FEM HD COCR CEMENTED Ø44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/12/2013

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.Examination of returned device found no evidence of product non-conformance.Root cause of the event was most likely attributed to third party debris, patient anatomy or surgical technique; however, a conclusive determination could not be made.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." number 11 states, "wear and/or deformation of articulating surfaces." under warnings and precautions, number 3 states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." number 4 states, "malalignment of components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure." number 5 states, "complete preclosure cleaning and removal of bone cement debris, metallic debris and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces." this report is number 2 of 2 mdrs filed for the same patient (reference 3002806535-2013-00286 and 3002806535-2016-00005).

Event Description

It was reported by the hospital that patient underwent primary surgery on (b)(6) 2009.Subsequently, revision procedure was performed on (b)(6) 2013 due to mechanical complication of the internal joint.

• Brand Name: RECAP FEM HD COCR CEMENTED Ø44MM
• 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: 5345423
• MDR Text Key: 35157083
• Report Number: 3002806535-2016-00005
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK021799
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 157244
• Device Lot Number: 1602602
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2008
• 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