MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING COMPONENT ; KNEE PROSTHESIS

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Insufficient Information (4580)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent partial knee arthroplasty.Subsequently, the patient underwent revision surgery due to an unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10.Item#:unknown ;lot#:unknown ;item name: unknown oxford tibial component  ; item#:unknown ;lot#:unknown ;item name: unknown oxford femoral component  ; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00192.3002806535 - 2023 - 00194.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford bearing component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.

Event Description

Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford bearing component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.

• Brand Name: UNKNOWN OXFORD BEARING COMPONENT
• 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: 17149101
• MDR Text Key: 317457627
• Report Number: 3002806535-2023-00193
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male