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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS C/LESS FEM COCR SZ LRG PC/HA; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF PKS C/LESS FEM COCR SZ LRG PC/HA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 10/28/2015
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 or deviation.The following could not be completed with the limited information provided: date implanted - ni.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under pma number p010014.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." requested but not returned by hospital.
 
Event Description
Patient was revised on the right side due to unicondylar component loosening.All components were removed and replaced.
 
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Brand Name
OXF PKS C/LESS FEM COCR SZ LRG PC/HA
Type of Device
PROSTHESIS, KNEE
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 Key5765332
MDR Text Key48655054
Report Number3002806535-2016-00513
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial
Report Date 06/03/2016
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? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number154927
Device Lot Number3478207
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2016
Initial Date FDA Received07/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2015
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
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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