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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD UNKNOWN KNEE; PROSTHESIS, KNEE

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BIOMET UK LTD UNKNOWN KNEE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Material Rupture (1546)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Rupture (2208)
Event Type  Injury  
Event Description
Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side on an unknown date.Patient follow-up results provided at 2.12 year post-implantation indicates patient underwent a revision surgery on an unknown date due to pain and swelling, traumatic acl rupture, loose tibial component and subsequent infection after acl reconstruction.There has been no further information provided and the patient outcome is unknown.
 
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).This information was originally reported on 1825034-2015-02246 which referenced a journal article written on a study that this patient took part in.
 
Manufacturer Narrative
This follow-up report is being filed to relay corrected information.
 
Event Description
Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side on an unknown date.Subsequently, patient underwent a acl reconstruction surgery on an unknown date due traumatic acl rupture.Following the acl reconstruction, the patient was revised due to infection 2.12 years after primary procedure.Upon opening it was noted that the tibial component was loose and there was destruction of the lateral compartment.All components were removed.Patient underwent two stage conversion to a total knee.
 
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Brand Name
UNKNOWN KNEE
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD
waterlon industrial estate
bridgend, south wales
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key4799668
MDR Text Key5881821
Report Number0001825034-2015-02260
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 Literature,literature
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/18/2016
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 Physician
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/29/2015
Initial Date FDA Received05/27/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/01/2016
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
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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