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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL IMPLANT; KNEE PROSTHESIS

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BIOMET UK LTD. UNKNOWN OXFORD TIBIAL IMPLANT; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 06/27/2023
Event Type  Injury  
Event Description
It was reported that the patient underwent a knee arthroplasty and approximately 17 years later a revision surgery was performed due to the fracture of the tibial component.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).G2: foreign: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product is unknown.
 
Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the product is not biomet uk ltd.Design control.This event will be reported on: 0009613350 - 2023 - 00534.Given this information, this medwatch will be voided.
 
Event Description
Upon reassessment of the reported event, it was determined this mdr was not filed under the current mfr number.The product is not under biomet uk ltd.Design control.This event will be reported on: 0009613350 - 2023 - 00534.Given this information, this medwatch will be voided.
 
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Brand Name
UNKNOWN OXFORD TIBIAL IMPLANT
Type of Device
KNEE PROSTHESIS
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 Key17405832
MDR Text Key319920537
Report Number3002806535-2023-00261
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/25/2023
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 Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberUNKNOWN OXFORD TIBIAL IMPLANT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/21/2023
Initial Date FDA Received07/27/2023
Supplement Dates Manufacturer Received07/21/2023
Supplement Dates FDA Received09/25/2023
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) Required Intervention; Hospitalization;
Patient Age80 YR
Patient SexMale
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