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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT; OXFORD PARTIAL KNEE SYSTEM
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BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT; OXFORD PARTIAL KNEE SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 08/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report: report source, foreign - event occurred in (b)(4).Revision surgery is scheduled for the (b)(6) 2021.We expect the product to be returned to zimmer biomet for investigation in due course.Associated products: medical product: unk oxford tibial component, catalog #: unknown, lot #: unknown.Medical product: unk oxford bearing, catalog #: unknown, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
 
Event Description
It was reported that the patient had an oxford partial knee in 2008.Subsequently, 2 months ago the patient heard a snap in the knee and afterwards experienced pain.The x-rays show that the femoral component is broken in two.Revision surgery is planned for the (b)(6) 2021.Attempts have been made but no further information has been provided at this time.
 
Event Description
It was reported that the patient had an oxford partial knee in 2008.Subsequently, 2 months ago the patient heard a snap in the knee and afterwards experienced pain.The x-rays show that the femoral component is broken in two.Revision surgery was performed on (b)(6) 2021.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: medical records received: patient's year of birth: 1949, gender: male.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay a correction together with additional information.We have received further information that the patient underwent revision surgery date: (b)(6) 2021.It has been confirmed that the patient was seen in næstved ambulatory regarding the fractured prosthesis, but after the consultation, the patient was referred to bispebjerg hospital, where the revision surgery was performed by dr.Bent olsen.Revision surgeon: (b)(6).Revision surgery hospital name : (b)(6) hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient had an oxford partial knee in 2008.Subsequently, 2 months ago the patient heard a snap in the knee and afterwards experienced pain.The x-rays show that the femoral component is broken in two.Revision surgery was performed on (b)(6) 2021.
 
Event Description
It was reported that the patient had an oxford partial knee in 2008.Subsequently, 2 months ago the patient heard a snap in the knee and afterwards experienced pain.The x-rays show that the femoral component is broken in two.Revision surgery was performed on (b)(6) 2021.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: femoral item number: 154602.Bearing item number: 159583.Tib tray item number: 154776.No lot numbers can be identified on these items.D10 associated products: medical product: oxf uni tib tray sz f rm pma.Catalog no.: 154776.Lot no.: unknown.Medical product: oxf anat brg rt lg size 4 pma.Catalog no.: 159583.Lot no.: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: it was reported that: the patient had an oxford partial knee in 2008.Subsequently, the patient heard a snap in the knee and afterwards experienced pain.The x-rays show that the femoral component is broken in two.Revision surgery is planned for the (b)(6) 2021.Products were returned to biomet uk for investigation, and forwarded to the research engineer for evaluation.An oxford partial knee femoral component, meniscal bearing and tibial tray have been revised after approximately 13 years due to fracture of the femoral component.The femoral component had fractured into two fragments.The cement mantle appeared uneven and there was a gap present between the cement mantle and the component on both fragments.Visual examination of the fracture surfaces also showed the presence of beach marks indicating that fatigue may have contributed to the failure.Extensive wear of the polyethylene was observed, which may have been caused by impingement and/or contact with the fractured femoral component.The inferior bearing surface showed scratches in the direction of articulation, which indicates that third body wear may also have been a contributing factor to the higher than expected wear rate.Immediate post-primary radiographs, surgical notes and patient information have not been provided and are required to determine the primary reason of the femoral component fracture.The definitive root cause of this event cannot be determined with the available information, however suboptimal cementing technique, impingement and repeat exposure to elevated stresses may have been contributing factors.A review of the complaints database shows that we have received no reported events for " revision due to implant fracture" for the same item number prior to the reported event.The severity of the reported event for similar complaints are in line with the risk file.Capa: no corrective or preventive action required at this time.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.
 
Event Description
It was reported that the patient had an oxford partial knee in 2008.Subsequently, 2 months ago the patient heard a snap in the knee and afterwards experienced pain.The x-rays show that the femoral component is broken in two.Revision surgery was performed on (b)(6) 2021.
 
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Brand Name
UNKNOWN OXFORD FEMORAL COMPONENT
Type of Device
OXFORD PARTIAL KNEE SYSTEM
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12412119
MDR Text Key269547301
Report Number3002806535-2021-00375
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number154602
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
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;
Patient SexMale
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