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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. 28MM BIOLOX DELTA MODULAR CERAMIC HEAD TYPE I TAPER PROSTHESIS, HIP

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BIOMET UK LTD. 28MM BIOLOX DELTA MODULAR CERAMIC HEAD TYPE I TAPER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component or Accessory Incompatibility
Event Date 04/07/2016
Event Type  Malfunction  
Manufacturer Narrative

The necessary manufacturing history was not provided for review. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Expiration date - ni. Manufacture date ¿ ni. This report is number 2 of 4 mdrs filed for the same patient (reference 3002806535-2016-00221 / 3002806535-2016-00762 / 1825034-2016-03413 / 1825034-2016-03785).

 
Event Description

During a bipolar hip arthroplasty, on the second attempted modular head used, the surgeon felt the ceramic head had restricted movement within the bipolar cup but implanted the components.

 
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Brand Name28MM BIOLOX DELTA MODULAR CERAMIC HEAD TYPE I TAPER
Type of DevicePROSTHESIS, 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
  CF31 3XA
0441656655
MDR Report Key5975141
Report Number3002806535-2016-00762
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number650-1158
Device LOT Number2015030291
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2016
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 NumberN/A

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