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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is an initial and final report combined as it has been established that no further information is available from the hospital.Medical product: unknown oxford femoral component, catalog #: unknown, lot #: unknown; medical product: unknown oxford tibial component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00374, 3002806535-2020-00373.As the product has not been received, the investigation was limited to the information provided; in addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed due to insufficient information.A review of the complaint database cannot be performed as reason for revision is unknown.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product not returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure was performed due to unknown reason.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: KNEE PROTHESIS
• 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: 10424314
• MDR Text Key: 203461108
• Report Number: 3002806535-2020-00372
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK OXFORD BEARING
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• 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): Hospitalization; Required Intervention