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 UNI TIB TRAY SZ C RM PMA; OXFORD CEMENTED TIBIAL TRAYS
  • 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 UNI TIB TRAY SZ C RM PMA; OXFORD CEMENTED TIBIAL TRAYS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 07/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00312, 3002806535-2021-00313.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2018.Subsequently, the oxford partial knee was revised to a total knee arthroplasty due to recurrent hematoma on (b)(6) 2021.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.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.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item 159577, 3 complaints reported with the item 161469 and 3 complaints reported with the item 154723 (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00312-1; 3002806535-2021-00313-1.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
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2018.Subsequently, the oxford partial knee was revised to a total knee arthroplasty due to recurrent hematoma on (b)(6) 2021.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6)2018.Subsequently, the oxford partial knee was revised to a total knee arthroplasty due to recurrent hematoma on (b)(6)2021.
 
Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay the corrected information: a review of the complaint database over the last 3 years has found 1 complaint reported with the items (including initiating complaint).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00312-2.3002806535-2021-00313-2.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXF UNI TIB TRAY SZ C RM PMA
Type of Device
OXFORD CEMENTED TIBIAL TRAYS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key12179573
MDR Text Key261953642
Report Number3002806535-2021-00314
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388899
UDI-Public05019279388899
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number154723
Device Lot Number007530
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-