Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 9 PMA; KNEE ARTHROPLASTY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 9 PMA; KNEE ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Joint Dislocation (2374)
Event Date 07/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Concomitant medical products: unknown oxford tibial tray, catalog #: unknown, lot #: unknown.Unknown oxford femoral component, catalog #: unknown, lot #: unknown.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.
 
Event Description
Patient legal counsel reported that patient underwent left total knee arthroplasty on (b)(6) 2018.Subsequently, the patient began experiencing pain in her left knee and had significant problems with mobility of the knee.It was discovered that the tibial polyethylene mobile bearing unit dislocated into the medial left knee joint space.A revision procedure was performed on (b)(6) 2019.This report is based on allegations set forth in plaintiff complaint and the allegations contained therein are unverified.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Biomet uk ltd was not been able to retrieve any further information relevant to this complaint as it was stated that no additional information would be available.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product and without receiving supporting documentation, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.H3 other text : product has not been returned.
 
Event Description
Patient legal counsel reported that patient underwent left total knee arthroplasty on (b)(6) 2018.Subsequently, the patient began experiencing pain in her left knee and had significant problems with mobility of the knee.It was discovered that the tibial polyethylene mobile bearing unit dislocated into the medial left knee joint space.A revision procedure was performed on (b)(6) 2019.This report is based on allegations set forth in plaintiff complaint and the allegations contained therein are unverified.
 
Event Description
Further information including medical documents have been received: patient legal counsel reported that patient underwent an initial left knee arthroplasty on (b)(6) 2018.Subsequently, the patient began experiencing pain in her left knee and had significant problems with mobility of the knee.The diagnosis was mechanical complication of left medial unicompartmental knee arthroplasty with atraumatic dislocation of tibial polyethylene mobile bearing component together with left knee deep medial collateral ligament incompetence.The patient also had significant osteoporosis.A conversion of the left medial unicompartmental knee arthroplasty to left total knee arthroplasty was performed on (b)(6) 2019.This report is based on allegations set forth in plaintiff complaint and the allegations contained therein are unverified.
 
Manufacturer Narrative
(b)(4).This final / follow-up report is being submitted to relay additional information.D11: medical product: oxf uni tib tray sz c lm pma, catalog #: 154722, lot #: 223650.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 803500.Additional information received: medical documents received (currently under review).-hospital: both implant and revision surgery was performed at (b)(6) , md.Doctor name: (b)(6).Implant date:(b)(6) 2018.Explant date: (b)(6) 2019.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.
 
Manufacturer Narrative
(b)(4).This final follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h10.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Additional information received: x-rays received.The provided pre-primary and post-revision x-rays are not relevant for this assessment.Therefore, only the thirteen post-primary and pre-revision x-rays, taken between 9 july 2018 and 4 july 2019, were considered.It is not possible to determine the cause of bearing dislocation with the information available at the time of writing of this assessment.However, suboptimal implant positioning and sizing, suboptimal cementing technique, suboptimal bone stock quality, as well as some degree of soft tissue laxity and imbalance as commented on by the revision surgeon may have been contributing factors.Full-limb ap x-rays, patient details such as height and weight, and analysis of the revised oxford components could help determine the cause of the adverse event.The manufacturing history records (mhrs) for the oxford anatomical bearing, tibial tray and femoral component have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product location unknown.
 
Event Description
Patient legal counsel reported that patient underwent an initial left knee arthroplasty on (b)(6) 2018.Subsequently, the patient began experiencing pain in her left knee and had significant problems with mobility of the knee.The diagnosis was mechanical complication of left medial unicompartmental knee arthroplasty with atraumatic dislocation of tibial polyethylene mobile bearing component together with left knee deep medial collateral ligament incompetence.The patient also had significant osteoporosis.A conversion of the left medial unicompartmental knee arthroplasty to left total knee arthroplasty was performed on (b)(6) 2019.This report is based on allegations set forth in plaintiff complaint and the allegations contained therein are unverified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXF ANAT BRG LT SM SIZE 9 PMA
Type of Device
KNEE ARTHROPLASTY
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key10361741
MDR Text Key201530769
Report Number3002806535-2020-00358
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/15/2022
Device Model NumberN/A
Device Catalogue Number159546
Device Lot Number312870
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEEH10
Patient Outcome(s) Hospitalization; Required Intervention;
-
-