MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD BEARING; 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 report source: foreign - event occurred in (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

We have received a manuscript titled, ¿the effect of body mass index on the outcome of cementless medial mobile bearing unicompartmental knee replacement.¿ authors to be confirmed: d w murray et al, 2021.The purpose of the study was to determine the effect of body mass index on the outcome of cementless medial mobile bearing unicompartmental knee replacement.Given an increasingly overweight population, unicompartmental knee replacements (ukrs) are being performed in patients with higher body mass indices (bmis).There are concerns that cemented fixation will not last.A prospective cohort of 1000 medial cementless mobile bearing ukr with a mean follow up of 6.6 years were analysed.Ukrs were categorised into four bmi groups: normal, overweight, obese class 1 and obese class 2.Implant survival was assessed using endpoints reoperation and revision.Functional outcomes were assessed.The study reported various reoperations and revisions in each bmi group which are listed below: bmi group - normal.Number of reoperations - 4.Number of revisions - 3.Details of reoperations/revisions indication for surgery.1 bearing exchange 1 bearing dislocations.1 lateral ukr 1 tibial avn.1 tkr 1 disease progression.1 arthroscopy 1 lateral meniscal tear.Bmi group - overweight.Number of reoperations - 13.Number of revisions - 9.Details of reoperations/revisions indication for surgery.1tkr pain.3 lateral ukrs disease progression.2 arthroscopies 1 for loose body and 1 for swelling.4 bearing exchange 4 bearing dislocations.1 washout debridement and closure 1 wound dehiscence.1 open washout 1 suspected infection.1 tibial component revision pain.Bmi group - obese (class 1).Number of reoperations - 9.Number of revisions - 6.Details of reoperations/revisions indication for surgery.2 arthroscopies 2 pain.3 bearing exchange 3 bearing dislocation.1 cemented femoral component 1 femoral component loosening.1 lateral ukr 1 disease progression.1 patellofemoral replacement pain.1 aspiration and mua pain and intermittent swelling/stiffness.Bmi group - obese (class 2).Number of reoperations - 2.Number of revisions - 2.Details of reoperations/revisions indication for surgery.2 tkr 1 lateral tibial fracture and 1 disease progression.This study found that the cementless mobile bearing ukr had low reoperation and revision rates in all bmi groups and there were no significant differences between the groups.Although higher bmi groups had slightly worse functional outcomes, the improvement in function postoperatively tended to be better.The study therefore suggests that high bmi should not be considered to be a contraindication to the cementless mobile bearing ukr.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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 body mass index on the outcome of cementless medial mobile bearing unicompartmental knee replacement.¿ authors to be confirmed: d w murray et al, 2021.The purpose of the study was to determine the effect of body mass index on the outcome of cementless medial mobile bearing unicompartmental knee replacement.Given an increasingly overweight population, unicompartmental knee replacements (ukrs) are being performed in patients with higher body mass indices (bmis).There are concerns that cemented fixation will not last.A prospective cohort of 1000 medial cementless mobile bearing ukr with a mean follow up of 6.6 years were analysed.Ukrs were categorised into four bmi groups: normal, overweight, obese class 1 and obese class 2.Implant survival was assessed using endpoints reoperation and revision.Functional outcomes were assessed.The study reported various reoperations and revisions in each bmi group which are listed below: 1.Bmi group - normal.Number of reoperations - 4.Number of revisions - 3.Details of reoperations/revisions indication for surgery.1 bearing exchange 1 bearing dislocations.1 lateral ukr 1 tibial avn.1 tkr 1 disease progression.1 arthroscopy 1 lateral meniscal tear.2.Bmi group - overweight.Number of reoperations - 13.Number of revisions - 9.Details of reoperations/revisions indication for surgery.1tkr pain.3 lateral ukrs disease progression.2 arthroscopies 1 for loose body and 1 for swelling.4 bearing exchange 4 bearing dislocations.1 washout debridement and closure 1 wound dehiscence.1 open washout 1 suspected infection.1 tibial component revision pain.3.Bmi group - obese (class 1).Number of reoperations - 9.Number of revisions - 6.Details of reoperations/revisions indication for surgery.2 arthroscopies 2 pain.3 bearing exchange 3 bearing dislocation.1 cemented femoral component 1 femoral component loosening.1 lateral ukr 1 disease progression.1 patellofemoral replacement pain.1 aspiration and mua pain and intermittent swelling/stiffness.4.Bmi group - obese (class 2).Number of reoperations - 2.Number of revisions - 2.Details of reoperations/revisions indication for surgery.2 tkr 1 lateral tibial fracture and 1 disease progression.This study found that the cementless mobile bearing ukr had low reoperation and revision rates in all bmi groups and there were no significant differences between the groups.Although higher bmi groups had slightly worse functional outcomes, the improvement in function postoperatively tended to be better.The study therefore suggests that high bmi should not be considered to be a contraindication to the cementless mobile bearing ukr.

• Brand Name: UNK OXFORD BEARING
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11648234
• MDR Text Key: 249970690
• Report Number: 3002806535-2021-00113
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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 OXFORD BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention