MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ E LM PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Fever (1858); Pain (1994)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf twin-peg cmntd fem lg pma catalog #: 161470 lot #: 2465527, medical product: oxf anat brg lt lg size 3 pma catalog #: 159554 lot #: 754110.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00861, 3002806535-2019-00860.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 left knee replacement procedure.5 years post-op, the patient began experiencing pain, redness and edema in his left leg together with a fever (cellulitis).These symptoms occurred 2-3 days after a return flight from italy.The patient was admitted to hospital for 7 days.Treatment included iv antibiotics, the patient also needed to wear compression stockings and keep leg elevated.

Manufacturer Narrative

(b)(4).D11: medical product: oxf twin-peg cmntd fem lg pma, catalog #: 161470, lot #: 2465527.Medical product: oxf anat brg lt lg size 3 pma, catalog #:159554, lot #: 754110.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00860-1, 3002806535-2019- 00861-1.This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The clinical report form indicated that the event is irrelevant to the device.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.

Event Description

It was reported that a patient underwent an initial left knee replacement procedure.5 years post-op, the patient began experiencing pain, redness and edema in his left leg together with a fever (cellulitis).These symptoms occurred 2-3 days after a return flight from italy.The patient was admitted to hospital for 7 days.Treatment included iv antibiotics, the patient also needed to wear compression stockings and keep leg elevated.

• Brand Name: OXF UNI TIB TRAY SZ E LM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9304124
• MDR Text Key: 166371565
• Report Number: 3002806535-2019-00859
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388929
• UDI-Public: 05019279388929
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 154726
• Device Lot Number: 2446499
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization