MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL COMPONENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); No Information (3190)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4 concomitant medical product - unknown oxford femoral component, therapy date - (b)(6) 2017.Concomitant medical product - unknown oxford bearing, therapy date - (b)(6) 2017.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-00147 and 3002806535-2018-00148.

Event Description

It was reported the patient underwent a partial oxford knee procedure and subsequently the patient underwent a revision due to unknown reasons.The patient was implanted with total knee implants during the revision procedure.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from 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 as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The event is not reportable because it was due to disease progression.

Event Description

The revision was due to the patient's arthritis spreading to the lateral compartment.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• 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: 7204975
• MDR Text Key: 97715990
• Report Number: 3002806535-2018-00146
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2017
• 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
• Patient Age: 69 YR