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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: unk oxford tibial component catalog #: not reported lot #: not reported, medical product: unk oxford bearing catalog #: not reported lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00882, 3002806535-2019-00883.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed on unknown date at (b)(6) hospital.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed on unknown date at (b)(6) hospital.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.

• Brand Name: UNK 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: 9368453
• MDR Text Key: 167771045
• Report Number: 3002806535-2019-00881
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2019
• 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