MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD CEMENTLESS UKR SYSTEM; KNEE PROTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial/final mdr report combined.Report source, foreign - event occurred in (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

We have received a manuscript titled, the effect of age on the outcomes of cementless mobile bearing unicompartmental knee replacements.Authors to be confirmed: h mohammad, d w murray et al, 2020.The purpose of the study was to determine the effect of age on the outcomes of cementless ukrs.Unicompartmental knee replacements (ukr) are being performed in patients with increasing demands and life expectancies with concerns that cement fixation will not last.Cementless fixation may offer a solution, but the long term results in different age groups has not been assessed.A prospective cohort of 1000 medial cementless mobile bearing ukr were analysed.Patients were categorised into four groups (<55, 55 to <65, 65 to <75 and >75 years).Implant survival was assessed using endpoints reoperation, revision and major revision requiring revision knee replacement components.Functional outcomes were assessed.The study reported various revision procedures and re-operations which are listed below: age group < 55 years; number of reoperations - 6; number of revision - 3; details of reoperations/revisions indication for surgery: 2 bearing exchange - 2 bearing dislocations; 2 arthroscopies - 1 for pain and 1 for knee swelling; 1 open debridement, lavage and bearing exchange - infection: 1 washout debridement and; closure - wound dehiscence.Age group 55 to <65 years: number of reoperations - 7; number of revision - 4, details of reoperations/revisions indication for surgery: 1 tkr - lateral tibial plateau fracture; 1 lateral ukr - disease progression; 2 arthroscopies - 1 for pain and 1 for lateral meniscal tear; 1 arthroscopy and washout - suspected infection; 1 cemented femoral component - femoral component loosening, revision: 1 tibial component revision - pain.Age group 65 to <75 years: number of reoperations - 11; number of revision - 9, details of reoperations/revisions indication for surgery: 3 bearing exchange - bearing dislocation; 1 dair and bearing exchange - suspected infection; 3 lateral ukrs - disease progression; 2 tkrs - 1 for pain and 1 for disease progression; 1 arthroscopy and arthrotomy - loose body; 1 aspiration and mua - pain and intermittent swelling/stiffness.Age group >75 years: number of reoperations - 6; number of revision - 6, details of reoperations/revisions indication for surgery: 3 bearing exchange - bearing dislocation; 1 lateral ukr - tibial avn; 1 tkr - disease progression; 1 patellofemoral replacement - pain.The cementless mobile bearing ukr has similar very low 10-year reoperation, revision and major revision rates and similar excellent clinical outcomes in all age groups.Cementless ukr should be used in all age groups and age should not be considered a contraindication.

• Brand Name: UNK OXFORD CEMENTLESS UKR SYSTEM
• 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: 11788751
• MDR Text Key: 249427509
• Report Number: 3002806535-2021-00148
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNK OXF CEMENTLESS UKR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention