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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Damage to Ligament(s) (1952)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: unknown oxford tibial component, catalog #: not reported, lot #: not reported, medical product: unknown oxford bearing, catalog #: not reported, lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00494, 3002806535-2019-00495.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that a patient underwent an initial left total knee procedure.Subsequently, the patient was revised due to acl rupture two years after the initial surgery.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that a patient underwent an initial left total knee procedure.Subsequently, the patient was revised due to acl rupture.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8686294
• MDR Text Key: 147566786
• Report Number: 3002806535-2019-00493
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention