MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; KNEE PROTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combined initial/final report and is being submitted to relay information.Report source, foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for an investigation as the product location is unknown.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.Unable to perform previous field action search as item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.

Event Description

Title: cemented medial mobile-bearing unicompartmental knee arthroplasty: effects of compliance with current indications on functional outcomes and long-term survival rates.Authors: luis bernal-fortich, md, andr_es correa-valderrama, md, andres echeverry-v_elez, md, willy stangl-herrera, md, erika cantor, msc, monica morales, msc, julio cesar palacio-villegas.Published on 31 december 2020.On 14 sep 2021, a journal article was retrieved by our clinical team from the journal of arthroscopy and joint surgery that reported a study from colombia.The objective of this study was to describe the functional outcomes and long-term survival rates of cemented medial mobile-bearing uka according to the compliance with current indications.This was a retrospective study of 78 patients with medial unicompartimental knee oa treated with mobile-bearing cemented uka (oxford phase-iii) between 2002 and 2012, with an average follow-up of 10.4 ± 3.4 years.When proper patient selection is carried out, cemented medial mobile-bearing uka offers good functional outcomes with a survival rate of 89.7% at 15 years of follow-up.The study reports revision due to progression of oa and polyethylene failure in two patients.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: KNEE PROTHESIS
• 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: 13800726
• MDR Text Key: 288598233
• Report Number: 3002806535-2022-00113
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: UNKNOWN OXF BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• 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