MAUDE Adverse Event Report: BIOMET UK LTD. TINBN COATED OXF FEM MED/UK; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Joint Swelling (2356); Reaction (2414)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent arthroscopy of the knee approximately three years post-implantation due to pain and swelling.It was reported recurrent swelling developed approximately two years post-implantation.During the arthroscopy, it was found there were defects in the coating on the femoral component, exposing the nickel underneath.There was reported to be no signs of loosening.Patient reportedly has developed synovitis.No revision procedure has been reported to date; no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: (b)(4).Concomitant medical products: 154720tnbn, tinbn coated oxf tib tray b lm, 2949882, 159547, oxf anat brg lt md size 3 pma, 2880367.This product is manufactured by zimmer biomet uk and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet uk manufactures a similar device that is cleared or distributed in the united states under pma number (b)(4).

Manufacturer Narrative

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.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.

• Brand Name: TINBN COATED OXF FEM MED/UK
• Type of Device: PROSTHESIS, KNEE
• 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: 6897014
• MDR Text Key: 87472589
• Report Number: 3002806535-2017-00900
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PSEE H10 NAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 154601TNBN
• Device Lot Number: 2949880
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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
• Treatment: UNKNOWN OXFORD BEARING; UNKNOWN OXFORD TIBIAL TRAY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR