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

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.

• 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 Key: 17405832
• MDR Text Key: 319920537
• Report Number: 3002806535-2023-00261
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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 Number: N/A
• Device Catalogue Number: UNKNOWN OXFORD TIBIAL IMPLANT
• Device Lot Number: UNKNOWN
• 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 Received: 07/27/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 09/25/2023
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male