MAUDE Adverse Event Report: BIOMET UK LTD. TAPERLOC LAT PC 11MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/22/2014

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; 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 10 states, "fretting and crevice corrosion can occur at interfaces between components." this report is number 2 of 2 mdr's filed for the same patient (reference 3002806535-2014-00059 & 3002806535-2015-04186).

Event Description

It was reported by the hospital that the patient underwent a hip replacement surgery on an unknown date.Subsequently, a revision procedure was performed on (b)(6) 2014 due to an unknown reason.No further information has been received.

• Brand Name: TAPERLOC LAT PC 11MM 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: 5323756
• MDR Text Key: 34260660
• Report Number: 3002806535-2015-04186
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK030055
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-103205
• Device Lot Number: 1161580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2006
• 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